Depressive Disorder, Major
Conditions
Brief summary
Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment. To evaluate the rescue option in non-responding patients. Safety of Duloxetine will also be assessed.
Interventions
DRUGDuloxetine
Capsule
DRUGPlacebo
Capsule
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients of 18 years of age at the screening visit or older 2. Meet criteria for severe Major Depressive Disorder (MDD) 3. Montgomery-Asberg-depression rating scale (MADRS) total score ≥ 30 and the 6-item Hamilton Depression scale (HAMD-6) score ≥12 at both screening (V1) visit and baseline (V2) visits 4. Clinical Global Impression of Severity (CGI-Severity) score ≥4 at both screening visit and baseline visit. 5. Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4 6. Patient willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol 7. Have a level of understanding sufficient to provide informed consent and to communicate with the investigators and site personnel. Informed consent document must be signed at screening visit, in accordance with Good Clinical Practice (GCP) and local regulatory requirements, prior to any study procedure
Exclusion criteria
1. More than two previous episodes of major depression that did not respond to adequate doses and duration (minimum of 6 weeks) of two different antidepressant therapies 2. Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode 3. Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major Depressive Disorder, in the investigator's judgment 4. Any previous diagnosis of a bipolar disorder, schizophrenia or OCD 5. Depression with catatonic features, depression with post-partum onset, or organic mental disorders 6. The presence of an Axis II disorder 7. MDD with psychotic features requiring neuroleptic treatment and/or interfering with patient's ability to provide informed consent, at investigator's discretion 8. History of substance abuse or dependence within the past year, excluding nicotine and caffeine, but including alcohol or benzodiazepines 9. Positive urine screen for drug abuse (cannabinoids, cocaine, opiates including methadone, or amphetamines) at screening 10. Epilepsy or a history of seizure disorder or of a treatment with anticonvulsant medication for epilepsy or seizures 11. Patients with acute liver injury (such as hepatitis) or severe cirrhosis (such as Child-Pugh Class C) 12. Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency 13. Patient with a known diagnosis of raised intraocular pressure, or at known risk of acute narrow-angle glaucoma 14. Serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require intervention/exclusion of study medication during the course of the study: cardiovascular (e.g. uncontrolled hypertension, abnormal initial ECG findings according to investigator judgement), respiratory, haematological, hepatic or gastrointestinal 15. End stage renal disease (estimated creatinine clearance ≤30 mL/min) and undergoing dialysis 16. Abnormal thyroid-stimulating hormone (TSH) concentrations, based on the performing laboratory's reference ranges. Patients must be clinically and chemically euthyroid at the time of randomization. Patients may be taking thyroid replacement therapy provided their dose is stable and their compliance is good for at least three months before the screening visit 17. Pregnancy (to be excluded by urine pregnancy test at screening visit) or breast-feeding 18. Sexually active woman of childbearing potential (i.e. not 6 months post-menopausal, or not surgically sterilized) not using a medically approved method of birth control (i.e. oral contraceptives, intrauterine device, or double-barrier) for at least one month prior to the screening visit and throughout the study 19. Participation in another clinical trial within 30 days prior to screening visit 20. Current treatment with Duloxetine for any indication and previous treatment with Duloxetine for psychiatric indications 21. Known hypersensitivity to Duloxetine or any of the inactive ingredients 22. History of oversensitivity to psychotropic drugs, in the investigator's judgment 23. Electro-convulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within one year prior to screening visit and during the study 24. Initiation or discontinuation of depression-oriented psychotherapeutic treatment (e.g. behaviour therapy, psychoanalytic therapy, cognitive therapy, etc) within 6 weeks prior to screening visit, or planned use of such treatment at any time during the study 25. Treatment with a Monoamine Oxidase Inhibitor (MAOI) within 14 days prior to baseline visit or the potential need to use an MAOI during the study or within 5 days after discontinuation of duloxetine 26. Treatment with Fluoxetine within 30 days prior to baseline visit 27. Treatment with any excluded medication listed in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 | At baseline and at Week 4. | The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) scored from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | At baseline and at Week 6 and Week 8. | HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | At baseline and at Week 1, 2 and Week 3. | The MADRS total score is used to measure the severity of depression. It is based total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | At baseline and at Week 6 and Week 8. | The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | At week 1, 2, 3 and week 4. | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | At week 6 and week 8. | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | At week 1, 2, 3 and week 4. | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | At week 6 and week 8. | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Percentage of Patients Reaching Remission at Week 8 | At week 8. | Remission is defined as a total Montgomery-Asberg Depression Rating Scale (MADRS) score of ≤ 12 at week 8. The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each and a total MADRS score ranging from 0 to 60. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | At baseline and at week 1, 2, 3 and week 4. | Clinical Global Impression (CGI) scales were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?. The CGI-SI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status. Reported is the number of patients per score by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre. |
| Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | At week 6 and week 8. | The Clinical Global Impressions scales of Severity of Illness (CGI-SI) were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status. Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. At week 8, within-group comparison versus week 4 was performed for each post-week 4 treatment group using Mc Nemar test. |
| Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | At week 1, 2, 3 and week 4. | The Clinical Global Impression of Improvement (CGI-I) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question: Compared to the patients condition at admission, how much has he or she changed?. The scale ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient status. Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre. |
| Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | At week 6 and week 8. | Clinical Global Impression (CGI) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question: Compared to the patients condition as admission, how much has he or she changed?. The CGI-I score ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient outcome. Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | At baseline and at Week 1, 2, 3 and Week 4. | HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | At week 6 and week 8. | Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 4 | At baseline and at week 4. | HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 4 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups | At baseline and at week 8. | HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 8 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Reason for Living (RFL) Questionaire at Baseline | At baseline. | The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered. The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections. The RFL uses a 6-point rating scale, with the total score ranging from 1 not at all important and to 6 extremely important. A higher score indicates more reasons to live (i.e. better outcome). Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups | At baseline and at week 8. | The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered. The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections. The RFL uses a 6-point rating scale, with the total score ranging from 1 not at all important and to 6 extremely important. A higher score indicates more reasons to live (i.e. better outcome). Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | 1 week prior to baseline and at baseline, week 1, 2, 3, 4, 5, 6, 7, 8 and week 10. | Number of patients with concomitant medication for anxiety and sleep taken at different timepoints. V1: Screening V2: Baseline V3: Week 1 V4: Week2 V5: Week 3 V6: Week 4 V7: Week 6 V8: Week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Number of Patients With Treatment Emergent Adverse Event | From start of treatment until 3 days after end of treatment, up to 120 days. | Number of patients with any adverse event occuring during on-treatment phase. Results are reported for treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Change From Baseline in Blood Pressure to Week 4 and Week 8 | At baseline, at week 4 and week 8. | Change from baseline in systolic and diastolic blood pressure (BP) to week 4 and week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Change From Baseline in Weight to Week 4 and Week 8 | At baseline, at week 4 and week 8. | Change from baseline in weight to week 4 and week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Number of Patients With Potentially Clinically Significant Laboratory Findings | Up to week 8. | Number of patients with potentially clinically significant abnormalities. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Number of Patients Withdrawn Due to Adverse Events | From start of treatment until 3 days after end of treatment, up to 120 days. | Number of patients withdrawn due to adverse events. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | At week 1, 2, 3 and week 4. | Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome. Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre. |
Participant flow
Recruitment details
Randomized (1:1), double-blind, two parallel-group trial comparing the clinical response to duloxetine 60 milligram (mg) and 120 mg per day in patients hospitalized for severe depression over a 8-week treatment period. At Week 4, participants classified by the investigator as non-responders were up-titrated to receive the higher dose duloxetine.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| 60 mg Duloxetine 1 capsule of 60 milligram (mg) duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food for the first 4 weeks of treatment. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MADRS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 120 mg of duloxetine (1 capsule of 60 mg duloxetine in the morning and 1 capsule of 60 mg duloxetine + 1 placebo capsule in the evening). | 167 |
| 120 mg Duloxetine From day 1 to day 3, 1 capsule of 60 mg duloxetine was administered orally once daily in the morning and 1 capsule of placebo was administered orally once daily in the evening, each with a glass of water, with or without food. From day 4 until Visit 6, the dose was escalated to 120 mg (forced titration), with 1 capsule of duloxetine administered orally once daily in the morning and one in the evening. At Visit 6 (week 4) patients were classified by the Montgomery-Asberg Depression Rating Scale (MARDS) as responders or non-responders. From week 4 to end of treatment responders (defined as ≥50% change in total MADRS score from baseline) continued with the same dosing regimen. Non-responders were up-titrated to 3 capsules a day, remaining at 120 mg dose of duloxetine (1 capsule of 60 mg duloxetine in the morning and one in the evening and 1 placebo capsule in the evening). | 171 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 9 |
| Overall Study | Lack of Efficacy | 4 | 10 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Not treated | 0 | 1 |
| Overall Study | Personal Reasons | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Refused continuing medication | 7 | 6 |
Baseline characteristics
| Characteristic | 60 mg Duloxetine | 120 mg Duloxetine | Total |
|---|---|---|---|
| Age, Continuous | 45.7 Years STANDARD_DEVIATION 13.9 | 43.9 Years STANDARD_DEVIATION 12.7 | 44.8 Years STANDARD_DEVIATION 13.3 |
| Investigator Country France | 64 Participants | 64 Participants | 128 Participants |
| Investigator Country Italy | 7 Participants | 6 Participants | 13 Participants |
| Investigator Country Russia | 81 Participants | 84 Participants | 165 Participants |
| Investigator Country South Africa | 15 Participants | 17 Participants | 32 Participants |
| Montgomery-Asberg Depression Rating Scale (MADRS) total score | 36.1 score on scale STANDARD_DEVIATION 4 | 36.0 score on scale STANDARD_DEVIATION 4.6 | 36.1 score on scale STANDARD_DEVIATION 4.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 161 Participants | 163 Participants | 324 Participants |
| Sex: Female, Male Female | 49 Participants | 38 Participants | 87 Participants |
| Sex: Female, Male Male | 118 Participants | 133 Participants | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 0 / 171 |
| other Total, other adverse events | 67 / 167 | 54 / 171 |
| serious Total, serious adverse events | 6 / 167 | 6 / 171 |
Outcome results
Primary
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4
The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) scored from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: At baseline and at Week 4.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 60 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 | -20.1 Units on a scale | Standard Deviation 10.6 |
| 120 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 | -19.9 Units on a scale | Standard Deviation 10 |
Comparison: The null hypothesis was that the mean change in MADRS total score between week 4 and baseline was the same for the 2 duloxetine treatment groups.p-value: 0.88ANCOVA
Secondary
Change From Baseline in Blood Pressure to Week 4 and Week 8
Change from baseline in systolic and diastolic blood pressure (BP) to week 4 and week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: At baseline, at week 4 and week 8.
Population: Treated Set (TRS): All randomised patients treated with at least one dose of study medication. Patients randomised but not treated with at least one dose of study drug were excluded, as they cannot contribute information on the drug effect. Only patients with non-missing data for this endpoint were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 60 mg Duloxetine | Change From Baseline in Blood Pressure to Week 4 and Week 8 | Systolic BP: Change from baseline to week 4. | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 12.7 |
| 60 mg Duloxetine | Change From Baseline in Blood Pressure to Week 4 and Week 8 | Systolic BP: Change from baseline to week 8 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| 60 mg Duloxetine | Change From Baseline in Blood Pressure to Week 4 and Week 8 | Diastolic BP: Change from baseline to week 4. | 1.9 Millimeters of mercury (mmHg) | Standard Deviation 9.5 |
| 60 mg Duloxetine | Change From Baseline in Blood Pressure to Week 4 and Week 8 | Diastolic BP: Change from baseline to week 8 | 2.3 Millimeters of mercury (mmHg) | Standard Deviation 9.6 |
| 120 mg Duloxetine | Change From Baseline in Blood Pressure to Week 4 and Week 8 | Diastolic BP: Change from baseline to week 8 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 20.3 |
| 120 mg Duloxetine | Change From Baseline in Blood Pressure to Week 4 and Week 8 | Systolic BP: Change from baseline to week 4. | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 13.2 |
| 120 mg Duloxetine | Change From Baseline in Blood Pressure to Week 4 and Week 8 | Diastolic BP: Change from baseline to week 4. | 0.7 Millimeters of mercury (mmHg) | Standard Deviation 9.6 |
| 120 mg Duloxetine | Change From Baseline in Blood Pressure to Week 4 and Week 8 | Systolic BP: Change from baseline to week 8 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 14.2 |
Secondary
Change From Baseline in Weight to Week 4 and Week 8
Change from baseline in weight to week 4 and week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: At baseline, at week 4 and week 8.
Population: Treated Set (TRS): All randomised patients treated with at least one dose of study medication. Patients randomised but not treated with at least one dose of study drug were excluded, as they cannot contribute information on the drug effect. Only patients with non-missing data for this endpoint were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 60 mg Duloxetine | Change From Baseline in Weight to Week 4 and Week 8 | Change from baseline to week 4 | 0.1 Kilogram (kg) | Standard Deviation 2 |
| 60 mg Duloxetine | Change From Baseline in Weight to Week 4 and Week 8 | Change from baseline to week 8 | 0.5 Kilogram (kg) | Standard Deviation 2.9 |
| 120 mg Duloxetine | Change From Baseline in Weight to Week 4 and Week 8 | Change from baseline to week 4 | 0.0 Kilogram (kg) | Standard Deviation 2.3 |
| 120 mg Duloxetine | Change From Baseline in Weight to Week 4 and Week 8 | Change from baseline to week 8 | 0.1 Kilogram (kg) | Standard Deviation 2.8 |
Secondary
Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups
The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered. The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections. The RFL uses a 6-point rating scale, with the total score ranging from 1 not at all important and to 6 extremely important. A higher score indicates more reasons to live (i.e. better outcome). Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Time frame: At baseline and at week 8.
Population: Only participants included in the FAS and with non-missing values for this endpoint were included in the analysis. Post-week 4 treatment groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 60 mg Duloxetine | Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups | 0.7 Score on a scale | Standard Deviation 0.9 |
| 120 mg Duloxetine | Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups | 0.4 Score on a scale | Standard Deviation 0.8 |
| 120 mg Duloxetine - Responder | Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups | 0.8 Score on a scale | Standard Deviation 0.8 |
| 120 mg Duloxetine - Non-Responder | Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups | 0.1 Score on a scale | Standard Deviation 0.9 |
Comparison: Within-group comparison, Week 8 versus baseline.p-value: <0.0001Student statistic t-test
Comparison: Within-group comparison, week 8 versus baseline.p-value: 0.001Student statistic t-test
Comparison: Within-group comparison, week 8 versus baseline.p-value: <0.0001Student statistic t-test
Comparison: Within-group comparison, week 8 versus baseline.p-value: 0.28Student statistic t-test
Secondary
Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4
HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: At baseline and at Week 1, 2, 3 and Week 4.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 60 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | Change from baseline to week 1 | -3.1 Units on a scale | Standard Deviation 3.6 |
| 60 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | Change from baseline to week 2 | -5.8 Units on a scale | Standard Deviation 4.6 |
| 60 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | Change from baseline to week 3 | -7.2 Units on a scale | Standard Deviation 4.4 |
| 60 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | Change from baseline to week 4 | -8.0 Units on a scale | Standard Deviation 4.8 |
| 120 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | Change from baseline to week 4 | -8.1 Units on a scale | Standard Deviation 4.7 |
| 120 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | Change from baseline to week 1 | -2.7 Units on a scale | Standard Deviation 3.3 |
| 120 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | Change from baseline to week 3 | -6.8 Units on a scale | Standard Deviation 4.4 |
| 120 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | Change from baseline to week 2 | -5.2 Units on a scale | Standard Deviation 4.2 |
Comparison: Comparison between treatment regimes at Week 4.p-value: 0.86ANCOVA
Secondary
Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups
HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Time frame: At baseline and at Week 6 and Week 8.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Only participants with non-missing values are reported. Post-week 4 treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 60 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 6 | -11.6 Units on a scale | Standard Deviation 3.5 |
| 60 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 8 | -12.3 Units on a scale | Standard Deviation 3.4 |
| 120 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 8 | -7.6 Units on a scale | Standard Deviation 5.1 |
| 120 mg Duloxetine | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 6 | -6.4 Units on a scale | Standard Deviation 4.4 |
| 120 mg Duloxetine - Responder | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 6 | -11.8 Units on a scale | Standard Deviation 3.3 |
| 120 mg Duloxetine - Responder | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 8 | -12.5 Units on a scale | Standard Deviation 3 |
| 120 mg Duloxetine - Non-Responder | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 6 | -5.5 Units on a scale | Standard Deviation 4.4 |
| 120 mg Duloxetine - Non-Responder | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 8 | -6.7 Units on a scale | Standard Deviation 5.4 |
Comparison: Within-group comparisons, week 8 versus baseline.p-value: <0.0001Signed Rank test
Comparison: Within-group comparison, week 8 versus baseline.p-value: <0.0001Singed Rank test
Comparison: Within-group comparison, week 8 versus baseline.p-value: <0.0001Singed Rank test
Comparison: Within-group comparison, week 8 versus baseline.p-value: <0.0001Signed Rank test
Secondary
Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 4
HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 4 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: At baseline and at week 4.
Population: Only participants in the FAS and with non-missing values for this endpoint were included in the analysis. Treatment regimen.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 60 mg Duloxetine | Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 4 | -13.0 Units on a score | Standard Deviation 9 |
| 120 mg Duloxetine | Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 4 | -13.6 Units on a score | Standard Deviation 9 |
Comparison: Comparison between HAMA scores between treatment regimens.p-value: 0.92ANCOVA
Secondary
Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups
HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 8 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Time frame: At baseline and at week 8.
Population: Only participants in the FAS and with non-missing values for this endpoint were included in the analysis. Post-week 4 treatment groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 60 mg Duloxetine | Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups | -19.6 Score on a scale | Standard Deviation 7.9 |
| 120 mg Duloxetine | Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups | -12.1 Score on a scale | Standard Deviation 10.1 |
| 120 mg Duloxetine - Responder | Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups | -21.0 Score on a scale | Standard Deviation 7.6 |
| 120 mg Duloxetine - Non-Responder | Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups | -10.8 Score on a scale | Standard Deviation 10 |
Comparison: Within-group comparison, week 8 versus baseline.p-value: <0.0001Student statistic t-test
Comparison: Within-group comparison, week 8 versus baseline.p-value: <0.0001Student statistic t-test
Comparison: Within-group comparison, week 8 versus baseline.p-value: <0.0001Student statistic t-test
Comparison: Within-group comparison, week 8 versus baseline.p-value: <0.0001Student statistic t-test
Secondary
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3
The MADRS total score is used to measure the severity of depression. It is based total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: At baseline and at Week 1, 2 and Week 3.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 60 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | Change from baseline to Week 1 | -8.3 Units on a scale | Standard Deviation 8 |
| 60 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | Change from baseline to Week 2 | -14.7 Units on a scale | Standard Deviation 9.9 |
| 60 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | Change from baseline to Week 3 | -18.1 Units on a scale | Standard Deviation 9.8 |
| 120 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | Change from baseline to Week 1 | -7.6 Units on a scale | Standard Deviation 7.3 |
| 120 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | Change from baseline to Week 2 | -13.5 Units on a scale | Standard Deviation 8.9 |
| 120 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | Change from baseline to Week 3 | -16.9 Units on a scale | Standard Deviation 9.3 |
Secondary
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups
The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Time frame: At baseline and at Week 6 and Week 8.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Only participants with non-missing values are reported. Post-week 4 treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 60 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 6 | -28.3 Units on a scale | Standard Deviation 7.9 |
| 60 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 8 | -29.8 Units on a scale | Standard Deviation 7.3 |
| 120 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 8 | -19.0 Units on a scale | Standard Deviation 11.8 |
| 120 mg Duloxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 6 | -16.1 Units on a scale | Standard Deviation 9.4 |
| 120 mg Duloxetine - Responder | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 6 | -28.1 Units on a scale | Standard Deviation 6.6 |
| 120 mg Duloxetine - Responder | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 8 | -29.5 Units on a scale | Standard Deviation 6.6 |
| 120 mg Duloxetine - Non-Responder | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 6 | -14.8 Units on a scale | Standard Deviation 10.4 |
| 120 mg Duloxetine - Non-Responder | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | Change from baseline to week 8 | -17.2 Units on a scale | Standard Deviation 12.3 |
Comparison: Within group comparisons were performed at week 8 versus baseline.p-value: <0.0001McNemar
Comparison: Within group comparisons were performed at week 8 versus baseline.p-value: <0.0001McNemar
Comparison: Within group comparisons were performed at week 8 versus baseline.p-value: <0.0001McNemar
Comparison: Within group comparisons were performed at week 8 versus baseline.p-value: <0.0001McNemar
Secondary
Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4
The Clinical Global Impression of Improvement (CGI-I) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question: Compared to the patients condition at admission, how much has he or she changed?. The scale ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient status. Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre.
Time frame: At week 1, 2, 3 and week 4.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Much improved | 29 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Much worse | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Much improved | 64 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Minimally improved | 46 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Minimally worse | 3 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Much worse | 2 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Very much worse | 1 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Minimally improved | 45 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | No change | 10 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Minimally improved | 75 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Minimally worse | 5 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Very much worse | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Very much improved | 22 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Minimally improved | 61 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | No change | 13 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Minimally worse | 5 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Much worse | 1 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Very much worse | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Very much improved | 31 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Much improved | 76 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | No change | 8 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Minimally worse | 4 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Much worse | 1 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Very much worse | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Very much improved | 38 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Much improved | 67 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Very much improved | 5 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | No change | 52 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Minimally improved | 76 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Minimally worse | 4 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Very much improved | 44 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | No change | 17 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Much improved | 60 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | No change | 11 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Minimally worse | 1 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Minimally worse | 2 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Very much worse | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Much worse | 1 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Much worse | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Very much worse | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Much improved | 78 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Minimally worse | 3 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Minimally improved | 34 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Very much worse | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | No change | 11 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Much improved | 25 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Very much improved | 2 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Minimally improved | 84 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | No change | 55 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Very much improved | 25 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Much worse | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Much worse | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Very much worse | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Much improved | 78 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Very much improved | 16 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Minimally improved | 53 Participants |
Comparison: At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre.p-value: 0.07Cochran-Mantel-Haenszel
Secondary
Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups
Clinical Global Impression (CGI) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question: Compared to the patients condition as admission, how much has he or she changed?. The CGI-I score ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient outcome. Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Time frame: At week 6 and week 8.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Minimally improved | 5 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much worse | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much improved | 35 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Minimally improved | 3 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | No change | 3 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much worse | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Minimally worse | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much improved | 64 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much improved | 25 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much worse | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much improved | 55 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | No change | 2 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Minimally worse | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much worse | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much worse | 1 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much worse | 3 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Minimally worse | 4 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much improved | 12 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Minimally improved | 12 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | No change | 6 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much improved | 6 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | No change | 7 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much improved | 39 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Minimally improved | 7 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much worse | 1 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much worse | 3 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much improved | 36 Participants |
| 120 mg Duloxetine | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Minimally worse | 3 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Minimally worse | 0 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Minimally improved | 5 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | No change | 2 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much improved | 38 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much improved | 71 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much worse | 0 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much worse | 0 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much improved | 30 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much worse | 0 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | No change | 2 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Minimally worse | 1 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Minimally improved | 2 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much worse | 0 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much improved | 61 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | No change | 13 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Minimally improved | 15 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much improved | 6 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much worse | 2 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much worse | 0 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much improved | 8 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much worse | 0 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | No change | 14 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Minimally worse | 1 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Minimally improved | 13 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Minimally worse | 1 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much improved | 27 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much improved | 26 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much worse | 2 Participants |
Secondary
Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4
Clinical Global Impression (CGI) scales were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?. The CGI-SI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status. Reported is the number of patients per score by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre.
Time frame: At baseline and at week 1, 2, 3 and week 4.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Most extremely ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Mildly ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Not at all ill | 8 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Borderline ill | 22 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Most extremely ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Mildly ill | 45 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Borderline ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Moderately ill | 53 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Not at all ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Markedly ill | 33 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Markedly ill | 18 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Severely ill | 5 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Most extremely ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Not at all ill | 17 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Borderline ill | 6 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Borderline ill | 30 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Moderately ill | 33 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Mildly ill | 48 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Moderately ill | 41 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Mildly ill | 20 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Markedly ill | 27 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Mildly ill | 34 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Severely ill | 3 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Moderately ill | 62 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Most extremely ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Not at all ill | 28 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Markedly ill | 93 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Borderline ill | 35 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Markedly ill | 62 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Not at all ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Moderately ill | 47 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Severely ill | 3 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Severely ill | 16 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Most extremely ill | 1 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Severely ill | 40 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Most extremely ill | 1 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Not at all ill | 6 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Severely ill | 5 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Most extremely ill | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Mildly ill | 56 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Most extremely ill | 1 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Moderately ill | 33 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Markedly ill | 17 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Not at all ill | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Mildly ill | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Moderately ill | 30 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Markedly ill | 87 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Severely ill | 51 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Most extremely ill | 2 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Not at all ill | 1 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Borderline ill | 3 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Mildly ill | 17 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Moderately ill | 64 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Markedly ill | 68 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Severely ill | 17 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 1 | Most extremely ill | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Borderline ill | 11 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Mildly ill | 48 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Moderately ill | 61 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 2 | Markedly ill | 39 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Not at all ill | 9 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Borderline ill | 29 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Moderately ill | 49 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Markedly ill | 22 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 3 | Severely ill | 4 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Not at all ill | 17 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Borderline ill | 46 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Mildly ill | 50 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Week 4 | Severely ill | 6 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4 | Baseline | Borderline ill | 0 Participants |
Comparison: At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre.p-value: 0.68Cochran-Mantel-Haenszel
Secondary
Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups
The Clinical Global Impressions scales of Severity of Illness (CGI-SI) were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status. Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. At week 8, within-group comparison versus week 4 was performed for each post-week 4 treatment group using Mc Nemar test.
Time frame: At week 6 and week 8.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Borderline ill | 30 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Not at all ill | 51 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Markedly ill | 1 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Borderline ill | 31 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Most extremely ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Severely ill | 1 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Not at all ill | 38 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Severely ill | 0 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Markedly ill | 1 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Mildly ill | 21 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Moderately ill | 4 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Mildly ill | 10 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Moderately ill | 4 Participants |
| 60 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Most extremely ill | 0 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Moderately ill | 6 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Mildly ill | 32 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Not at all ill | 1 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Borderline ill | 9 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Moderately ill | 11 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Markedly ill | 12 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Severely ill | 4 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Most extremely ill | 1 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Not at all ill | 6 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Borderline ill | 23 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Mildly ill | 19 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Markedly ill | 10 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Severely ill | 5 Participants |
| 120 mg Duloxetine | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Most extremely ill | 1 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Moderately ill | 2 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Severely ill | 0 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Moderately ill | 3 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Not at all ill | 41 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Markedly ill | 1 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Mildly ill | 10 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Not at all ill | 54 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Borderline ill | 40 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Severely ill | 0 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Mildly ill | 21 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Markedly ill | 1 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Most extremely ill | 0 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Most extremely ill | 0 Participants |
| 120 mg Duloxetine - Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Borderline ill | 39 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Most extremely ill | 1 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Not at all ill | 5 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Severely ill | 7 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Borderline ill | 13 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Mildly ill | 16 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Mildly ill | 15 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Not at all ill | 2 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Moderately ill | 11 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Borderline ill | 6 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Most extremely ill | 1 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Markedly ill | 12 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Markedly ill | 14 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Severely ill | 6 Participants |
| 120 mg Duloxetine - Non-Responder | Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Moderately ill | 19 Participants |
Comparison: At week 8, within-group comparison versus week 4 was performed.p-value: <0.0001Signed Rank test
Comparison: At week 8, within-group comparison versus week 4 was performed.p-value: <0.0001Signed Rank test
Comparison: At week 8, within-group comparison versus week 4 was performed.p-value: <0.0001Signed Rank test
Comparison: At week 8, within-group comparison versus week 4 was performed.p-value: <0.0001Signed Rank test
Secondary
Number of Patients Withdrawn Due to Adverse Events
Number of patients withdrawn due to adverse events. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: From start of treatment until 3 days after end of treatment, up to 120 days.
Population: Treated Set (TRS): All randomised patients treated with at least one dose of duloxetine. Participants randomised but not treated with at least one dose of duloxetine were excluded, as they cannot contribute information on the drug effect. Treatment regimen.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 60 mg Duloxetine | Number of Patients Withdrawn Due to Adverse Events | 11 Participants |
| 120 mg Duloxetine | Number of Patients Withdrawn Due to Adverse Events | 9 Participants |
Secondary
Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep
Number of patients with concomitant medication for anxiety and sleep taken at different timepoints. V1: Screening V2: Baseline V3: Week 1 V4: Week2 V5: Week 3 V6: Week 4 V7: Week 6 V8: Week 8. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: 1 week prior to baseline and at baseline, week 1, 2, 3, 4, 5, 6, 7, 8 and week 10.
Population: Only participants included in the treated set and with non-missing values for this endpoint were included in the analysis. Treatment regimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V2 - V3 | 95 Participants |
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V5 - V6 | 55 Participants |
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V1 - V2 | 93 Participants |
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Patients with medication taken between V3 - V4 | 80 Participants |
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V7 - V8 | 51 Participants |
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken before V1 | 65 Participants |
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken after V8 (week 10) | 18 Participants |
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V4 - V5 | 62 Participants |
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication not taken between two consecutive visits | 8 Participants |
| 60 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V6 - V7 | 47 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication not taken between two consecutive visits | 8 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken before V1 | 59 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V1 - V2 | 88 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V2 - V3 | 89 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Patients with medication taken between V3 - V4 | 84 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V4 - V5 | 67 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V5 - V6 | 58 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V6 - V7 | 49 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken between V7 - V8 | 52 Participants |
| 120 mg Duloxetine | Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep | Number of patients with medication taken after V8 (week 10) | 10 Participants |
Secondary
Number of Patients With Potentially Clinically Significant Laboratory Findings
Number of patients with potentially clinically significant abnormalities. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: Up to week 8.
Population: Only participants included in the treated set (TRS) and with non-missing values for each laboratory parameter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Calcium Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Creatine kinase Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Monocytes Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Creatine kinase Increase | 6 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Chloride Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Haematocrit Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | White blood cell ct. Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Haenatocrit Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Phosphate Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Red blood cell ct. Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Monocytes Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Red blood cell ct. Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Phosphate Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | MCV Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Platelets Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | MCV Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | White blood cell ct. Decrease | 1 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | MCHC Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Bicarbonate Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | MCHC Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Sodium Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Eosinophils Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | AST/GOT, SGOT Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Basophils Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Eosinophils Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Basophils Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | AST/GOT, SGOT Increase | 2 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Lymphocytes Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Potassium Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Neut., bands (stabs) Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Lymphocytes Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Neut., bands (stabs) Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Alkaline phosphatase Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Sodium Decrease | 1 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Potassium Increase | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Calcium Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | GGT Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Chloride Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Bicarbonate Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | ALT/GPT, SGPT Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Platelets Decrease | 0 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | ALT/GPT, SGPT Increase | 3 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | GGT Increase | 2 Participants |
| 60 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Alkaline phosphatase Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | GGT Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | White blood cell ct. Decrease | 2 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | White blood cell ct. Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Platelets Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Platelets Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Lymphocytes Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Monocytes Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Monocytes Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Sodium Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Sodium Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Potassium Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Calcium Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Chloride Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Chloride Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Phosphate Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Phosphate Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Bicarbonate Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Bicarbonate Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | AST/GOT, SGOT Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | AST/GOT, SGOT Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Alkaline phosphatase Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Alkaline phosphatase Increase | 1 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | GGT Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | MCHC Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Creatine kinase Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Creatine kinase Increase | 3 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Haematocrit Decrease | 1 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Haenatocrit Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Red blood cell ct. Decrease | 1 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Red blood cell ct. Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | MCV Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | MCV Increase | 1 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | MCHC Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Eosinophils Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Eosinophils Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Basophils Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Basophils Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Lymphocytes Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Neut., bands (stabs) Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Neut., bands (stabs) Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Potassium Increase | 1 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | Calcium Increase | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | ALT/GPT, SGPT Decrease | 0 Participants |
| 120 mg Duloxetine | Number of Patients With Potentially Clinically Significant Laboratory Findings | ALT/GPT, SGPT Increase | 1 Participants |
Secondary
Number of Patients With Treatment Emergent Adverse Event
Number of patients with any adverse event occuring during on-treatment phase. Results are reported for treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: From start of treatment until 3 days after end of treatment, up to 120 days.
Population: Treated Set (TRS): All randomised patients treated with at least one dose of duloxetine. Participants randomised but not treated with at least one dose of duloxetine were excluded, as they cannot contribute information on the drug effect. Treatment regimen.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 60 mg Duloxetine | Number of Patients With Treatment Emergent Adverse Event | 97 Participants |
| 120 mg Duloxetine | Number of Patients With Treatment Emergent Adverse Event | 89 Participants |
Secondary
Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4
Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome. Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre.
Time frame: At week 1, 2, 3 and week 4.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Very much worse | 4 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Missing | 2 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | No change | 17 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | A little worse | 8 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Much worse | 1 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Very much worse | 1 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Much better | 45 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Very much better | 7 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Much better | 66 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | No change | 40 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | A little worse | 3 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | A little worse | 3 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Much worse | 1 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Much worse | 0 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Very much worse | 2 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Missing | 2 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Missing | 1 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Very much better | 35 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | A little better | 49 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Missing | 1 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | No change | 10 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Very much better | 22 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Very much better | 43 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Very much worse | 2 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Much better | 66 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | A little better | 62 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | A little better | 38 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | No change | 11 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Much better | 63 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | A little worse | 3 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Much worse | 0 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | A little better | 56 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Very much worse | 1 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Very much better | 7 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Much better | 26 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | A little better | 83 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | A little worse | 7 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Very much better | 20 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Missing | 0 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Very much better | 34 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Much better | 62 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | A little worse | 2 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Very much worse | 1 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Missing | 0 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Very much better | 49 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | A little worse | 3 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Much worse | 4 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | No change | 47 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Much worse | 0 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Very much worse | 0 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Missing | 0 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Much better | 56 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | A little better | 73 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | No change | 18 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | A little worse | 2 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Much worse | 1 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 2 | Very much worse | 0 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | A little better | 50 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | No change | 19 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 3 | Much worse | 2 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | Much better | 64 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | A little better | 37 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 4 | No change | 12 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4 | Week 1 | Missing | 0 Participants |
Comparison: Before testing, PGI-I items were pooled to reduce the possible number of classes. The 3 classes used (instead of 7 items) were: 1-2= improved, 3-5=Stable, 6-7=Worsened. At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre.p-value: 1Cochran-Mantel-Haenszel
Secondary
Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups
Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Time frame: At week 6 and week 8.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Missing | 0 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much better | 26 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | No change | 4 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much better | 48 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much better | 37 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | A little better | 5 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | No change | 4 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | A little worse | 1 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much worse | 1 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much worse | 0 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Missing | 0 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much better | 62 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | A little better | 4 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | A little worse | 0 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much worse | 0 Participants |
| 60 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much worse | 0 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | No change | 8 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much worse | 1 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much better | 33 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much worse | 4 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | A little worse | 2 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much worse | 2 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Missing | 1 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | A little better | 17 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | No change | 5 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Missing | 1 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much better | 17 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | A little worse | 2 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much better | 25 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much worse | 4 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much better | 7 Participants |
| 120 mg Duloxetine | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | A little better | 11 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | A little worse | 1 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much better | 34 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | A little worse | 0 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much worse | 0 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much worse | 0 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much better | 72 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | A little better | 4 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much better | 61 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Missing | 0 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | No change | 2 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | A little better | 7 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Missing | 0 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much worse | 0 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | No change | 4 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much better | 27 Participants |
| 120 mg Duloxetine - Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much worse | 0 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | A little better | 18 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much better | 5 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | No change | 15 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | A little better | 18 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | No change | 12 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | A little worse | 1 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | A little worse | 1 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much worse | 2 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Very much worse | 1 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Missing | 0 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much better | 17 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much better | 10 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Much worse | 2 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Missing | 0 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 6 | Much better | 25 Participants |
| 120 mg Duloxetine - Non-Responder | Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups | Week 8 | Very much worse | 1 Participants |
Secondary
Percentage of Patients Reaching Remission at Week 8
Remission is defined as a total Montgomery-Asberg Depression Rating Scale (MADRS) score of ≤ 12 at week 8. The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each and a total MADRS score ranging from 0 to 60. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Time frame: At week 8.
Population: Full-Analysis Set (FAS): This included all participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 60 mg Duloxetine | Percentage of Patients Reaching Remission at Week 8 | Yes | 88.5 Percentage of participants |
| 60 mg Duloxetine | Percentage of Patients Reaching Remission at Week 8 | No | 11.5 Percentage of participants |
| 120 mg Duloxetine | Percentage of Patients Reaching Remission at Week 8 | No | 58.6 Percentage of participants |
| 120 mg Duloxetine | Percentage of Patients Reaching Remission at Week 8 | Yes | 41.4 Percentage of participants |
| 120 mg Duloxetine - Responder | Percentage of Patients Reaching Remission at Week 8 | No | 11.3 Percentage of participants |
| 120 mg Duloxetine - Responder | Percentage of Patients Reaching Remission at Week 8 | Yes | 88.7 Percentage of participants |
| 120 mg Duloxetine - Non-Responder | Percentage of Patients Reaching Remission at Week 8 | Yes | 28.1 Percentage of participants |
| 120 mg Duloxetine - Non-Responder | Percentage of Patients Reaching Remission at Week 8 | No | 71.9 Percentage of participants |
Secondary
Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6)
Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: At week 1, 2, 3 and week 4.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 60 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Week 1 | 12.0 Percentage of Participants |
| 60 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Week 2 | 32.5 Percentage of Participants |
| 60 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Week 3 | 42.8 Percentage of Participants |
| 60 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Week 4 | 55.4 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Week 4 | 58.2 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Week 1 | 10.0 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Week 3 | 44.1 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | Week 2 | 26.5 Percentage of Participants |
Comparison: Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.p-value: 0.57Regression, Logistic
Secondary
Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale
Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: At week 1, 2, 3 and week 4.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment-regimen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 60 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Week 1 | 14.5 Percentage of Participants |
| 60 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Week 2 | 33.7 Percentage of Participants |
| 60 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Week 3 | 50.0 Percentage of Participants |
| 60 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Week 4 | 59.0 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Week 4 | 64.1 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Week 1 | 8.2 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Week 3 | 46.5 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | Week 2 | 31.2 Percentage of Participants |
Comparison: Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.p-value: 0.32Regression, Logistic
Secondary
Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group
Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Time frame: At week 6 and week 8.
Population: Full-Analysis Set (FAS): This included all participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 60 mg Duloxetine | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Week 6 | 90.6 Percentage of participants |
| 60 mg Duloxetine | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Week 8 | 92.7 Percentage of participants |
| 120 mg Duloxetine | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Week 8 | 60.0 Percentage of participants |
| 120 mg Duloxetine | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Week 6 | 47.1 Percentage of participants |
| 120 mg Duloxetine - Responder | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Week 6 | 90.6 Percentage of participants |
| 120 mg Duloxetine - Responder | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Week 8 | 95.3 Percentage of participants |
| 120 mg Duloxetine - Non-Responder | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Week 6 | 31.3 Percentage of participants |
| 120 mg Duloxetine - Non-Responder | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | Week 8 | 46.9 Percentage of participants |
Secondary
Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups
Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Time frame: At week 6 and week 8.
Population: Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 60 mg Duloxetine | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Week 6 | 94.8 Percentage of Participants |
| 60 mg Duloxetine | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Week 8 | 93.8 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Week 8 | 65.7 Percentage of Participants |
| 120 mg Duloxetine | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Week 6 | 52.9 Percentage of Participants |
| 120 mg Duloxetine - Responder | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Week 6 | 98.1 Percentage of Participants |
| 120 mg Duloxetine - Responder | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Week 8 | 98.1 Percentage of Participants |
| 120 mg Duloxetine - Non-Responder | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Week 6 | 39.1 Percentage of Participants |
| 120 mg Duloxetine - Non-Responder | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | Week 8 | 54.7 Percentage of Participants |
Secondary
Reason for Living (RFL) Questionaire at Baseline
The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered. The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections. The RFL uses a 6-point rating scale, with the total score ranging from 1 not at all important and to 6 extremely important. A higher score indicates more reasons to live (i.e. better outcome). Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Time frame: At baseline.
Population: Only participants in the FAS and with non-missing values for this endpoint were included in the analysis. Treatment regimen.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 60 mg Duloxetine | Reason for Living (RFL) Questionaire at Baseline | 3.8 Score on a scale | Standard Deviation 1.1 |
| 120 mg Duloxetine | Reason for Living (RFL) Questionaire at Baseline | 3.7 Score on a scale | Standard Deviation 1 |