Generalized Anxiety Disorder
Conditions
Keywords
anxiety
Brief summary
This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder
Interventions
DRUGDuloxetine
60 to 120 mg, capsules, oral, once a day for 15 weeks
DRUGPlacebo
placebo capsules, oral, once a day for 15 weeks
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Psychiatric Diagnosis of generalized anxiety disorder (GAD) * Outpatients * Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD * Clinical Global Impression (CGI) of Severity Score of at least moderate * Sheehan Disability Scale (SDS) Global Functioning Impairment Score \>= 12
Exclusion criteria
* Pregnancy or breast feeding * Serious medical illness * Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months * panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year * lifetime history of bipolar or psychosis * Any unstable serious medical condition for which duloxetine would not be allowed * Any use of medications that are not allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint | Baseline, Week 15 | A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint | Week 15 | Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). |
| Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Baseline, Week 15 | BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. |
| Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint | Baseline, Week 15 | The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. |
| Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Baseline, Week 15 | VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). |
| Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint | Baseline, Week 15 | A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' |
| Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Baseline, Week 15 | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine 60 to 120 mg, capsules, oral, once a day for 15 weeks | 108 |
| Placebo placebo capsules, oral, once a day for 15 weeks | 102 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 3 |
| Overall Study | Lack of Efficacy | 4 | 13 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 4 |
| Overall Study | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | Duloxetine | Total | Placebo |
|---|---|---|---|
| Age Continuous | 37.26 years STANDARD_DEVIATION 11.85 | 37.63 years STANDARD_DEVIATION 11.92 | 38.02 years STANDARD_DEVIATION 12.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 108 Participants | 210 Participants | 102 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 108 participants | 210 participants | 102 participants |
| Sex: Female, Male Female | 50 Participants | 106 Participants | 56 Participants |
| Sex: Female, Male Male | 58 Participants | 104 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 67 / 108 | 45 / 102 |
| serious Total, serious adverse events | 0 / 108 | 1 / 102 |
Outcome results
Primary
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Time frame: Baseline, Week 15
Population: Participants with a baseline and at least one post-baseline result within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint | Baseline | 12.76 Units on a scale | Standard Deviation 2.89 |
| Duloxetine | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint | Change from Baseline | -6.38 Units on a scale | Standard Deviation 4.44 |
| Placebo | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint | Baseline | 13.56 Units on a scale | Standard Deviation 2.96 |
| Placebo | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint | Change from Baseline | -5.29 Units on a scale | Standard Deviation 4.78 |
p-value: 0.00695% CI: [-2.76, -0.48]ANCOVA
Secondary
Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame: Baseline, Week 15
Population: Participants with a baseline and at least one post-baseline result within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Pain Right Now Baseline | 2.21 Units on a Scale | Standard Deviation 2.58 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain,Walking Ability, Change | -0.63 Units on a Scale | Standard Deviation 2.01 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Least Pain Baseline | 1.17 Units on a Scale | Standard Deviation 1.51 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Int. of Pain, Normal Work, Baseline | 2.53 Units on a Scale | Standard Deviation 2.77 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Pain Right Now Change | -1.41 Units on a Scale | Standard Deviation 2.29 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, General Activity, Baseline | 2.60 Units on a Scale | Standard Deviation 2.81 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Int. of Pain, Relations with Others, Baseline | 2.01 Units on a Scale | Standard Deviation 2.59 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Average Pain Baseline | 2.36 Units on a Scale | Standard Deviation 2.26 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Int. of Pain, Relations with Others, Change | -1.07 Units on a Scale | Standard Deviation 2.22 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, General Activity, Change | -1.43 Units on a Scale | Standard Deviation 2.4 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Sleep, Baseline | 2.55 Units on a Scale | Standard Deviation 3.09 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Worst Pain Change | -1.78 Units on a Scale | Standard Deviation 2.44 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Sleep, Change | -1.16 Units on a Scale | Standard Deviation 2.56 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Mood, Baseline | 2.97 Units on a Scale | Standard Deviation 3.04 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Enjoyment of Life, Baseline | 2.51 Units on a Scale | Standard Deviation 2.8 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Average Pain Change | -1.25 Units on a Scale | Standard Deviation 1.94 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Int. of Pain, Normal Work, Change | -1.25 Units on a Scale | Standard Deviation 2.54 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Mood, Change | -1.49 Units on a Scale | Standard Deviation 2.71 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Enjoyment of Life, Change | -1.27 Units on a Scale | Standard Deviation 2.73 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Least Pain Change | -0.67 Units on a Scale | Standard Deviation 1.32 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Mean Interference Score, Baseline | 2.36 Units on a Scale | Standard Deviation 2.46 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain,Walking Ability, Baseline | 1.31 Units on a Scale | Standard Deviation 2.07 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Mean Interference Score, Change | -1.18 Units on a Scale | Standard Deviation 2.13 |
| Duloxetine | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Worst Pain Baseline | 3.39 Units on a Scale | Standard Deviation 2.84 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Mean Interference Score, Change | -1.04 Units on a Scale | Standard Deviation 1.84 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Worst Pain Baseline | 4.22 Units on a Scale | Standard Deviation 3.03 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Worst Pain Change | -1.88 Units on a Scale | Standard Deviation 2.78 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Least Pain Baseline | 1.51 Units on a Scale | Standard Deviation 1.81 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Least Pain Change | -0.45 Units on a Scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Average Pain Baseline | 2.77 Units on a Scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Average Pain Change | -0.97 Units on a Scale | Standard Deviation 2.06 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Pain Right Now Baseline | 2.30 Units on a Scale | Standard Deviation 2.68 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, General Activity, Baseline | 2.66 Units on a Scale | Standard Deviation 2.69 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, General Activity, Change | -1.06 Units on a Scale | Standard Deviation 2.43 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Mood, Baseline | 3.40 Units on a Scale | Standard Deviation 2.87 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Mood, Change | -1.44 Units on a Scale | Standard Deviation 2.57 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain,Walking Ability, Baseline | 1.56 Units on a Scale | Standard Deviation 2.16 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain,Walking Ability, Change | -0.47 Units on a Scale | Standard Deviation 1.95 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Int. of Pain, Normal Work, Baseline | 2.44 Units on a Scale | Standard Deviation 2.67 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Int. of Pain, Normal Work, Change | -0.96 Units on a Scale | Standard Deviation 2.43 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Int. of Pain, Relations with Others, Baseline | 2.01 Units on a Scale | Standard Deviation 2.52 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Int. of Pain, Relations with Others, Change | -0.88 Units on a Scale | Standard Deviation 2.07 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Sleep, Baseline | 3.23 Units on a Scale | Standard Deviation 3.15 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Sleep, Change | -1.45 Units on a Scale | Standard Deviation 2.68 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Severity of Pain Right Now Change | -0.77 Units on a Scale | Standard Deviation 2.54 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Enjoyment of Life, Baseline | 2.62 Units on a Scale | Standard Deviation 2.37 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Interference of Pain, Enjoyment of Life, Change | -0.99 Units on a Scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint | Mean Interference Score, Baseline | 2.56 Units on a Scale | Standard Deviation 2.25 |
p-value: 0.36795% CI: [-0.71, 0.26]ANCOVA
p-value: 0.39595% CI: [-0.59, 0.24]ANCOVA
p-value: 0.73195% CI: [-0.63, 0.44]ANCOVA
p-value: 0.12595% CI: [-0.93, 0.11]ANCOVA
p-value: 0.01495% CI: [-0.75, -0.09]ANCOVA
p-value: 0.01295% CI: [-0.93, -0.11]ANCOVA
p-value: 0.00295% CI: [-1.14, -0.25]ANCOVA
p-value: 0.10195% CI: [-0.87, 0.08]ANCOVA
p-value: 0.25295% CI: [-0.83, 0.22]ANCOVA
p-value: 0.14995% CI: [-0.72, 0.11]ANCOVA
p-value: 0.18695% CI: [-0.85, 0.17]ANCOVA
p-value: 0.2295% CI: [-0.67, 0.16]ANCOVA
Secondary
Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.
Time frame: Baseline, Week 15
Population: Participants with a baseline and at least one post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Work- Baseline (N=101,N=94) | 5.94 Units on a scale | Standard Deviation 2.01 |
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Work- Change(N=101,N=94) | -3.27 Units on a scale | Standard Deviation 3.06 |
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Social/Leisure - Baseline | 5.84 Units on a scale | Standard Deviation 1.89 |
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Social/Leisure - Change | -3.21 Units on a scale | Standard Deviation 2.9 |
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Family Life - Baseline | 5.50 Units on a scale | Standard Deviation 1.78 |
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Family Life - Change | -3.07 Units on a scale | Standard Deviation 2.55 |
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Global Functional Impairment Total Score -Baseline | 17.24 Units on a scale | Standard Deviation 4.58 |
| Duloxetine | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Global Functional Impairment Total Score -Change | -9.51 Units on a scale | Standard Deviation 7.56 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Global Functional Impairment Total Score -Change | -7.71 Units on a scale | Standard Deviation 7.15 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Work- Baseline (N=101,N=94) | 5.85 Units on a scale | Standard Deviation 1.72 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Family Life - Baseline | 5.39 Units on a scale | Standard Deviation 1.83 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Work- Change(N=101,N=94) | -2.59 Units on a scale | Standard Deviation 2.69 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Global Functional Impairment Total Score -Baseline | 17.05 Units on a scale | Standard Deviation 4.52 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Social/Leisure - Baseline | 5.73 Units on a scale | Standard Deviation 1.94 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Family Life - Change | -2.45 Units on a scale | Standard Deviation 2.43 |
| Placebo | Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores | Symptoms Disrupted Social/Leisure - Change | -2.60 Units on a scale | Standard Deviation 2.68 |
p-value: 0.07695% CI: [-1.29, 0.06]ANCOVA
p-value: 0.1495% CI: [-1.16, 0.17]ANCOVA
p-value: 0.08795% CI: [-1.14, 0.08]ANCOVA
p-value: 0.08395% CI: [-3.46, 0.21]ANCOVA
Secondary
Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint
The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.
Time frame: Baseline, Week 15
Population: Participants with a baseline and at least one post-baseline result within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint | Baseline | 24.50 Units on a scale | Standard Deviation 5.81 |
| Duloxetine | Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint | Change from Baseline | -14.42 Units on a scale | Standard Deviation 9.05 |
| Placebo | Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint | Baseline | 24.24 Units on a scale | Standard Deviation 5.16 |
| Placebo | Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint | Change from Baseline | -11.62 Units on a scale | Standard Deviation 8.31 |
p-value: 0.02495% CI: [-4.78, -0.34]ANCOVA
Secondary
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Time frame: Baseline, Week 15
Population: Participants with a baseline and at least one post-baseline result within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint | Baseline | 6.90 Units on a Scale | Standard Deviation 3.49 |
| Duloxetine | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint | Change from Baseline | -2.95 Units on a Scale | Standard Deviation 3.82 |
| Placebo | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint | Baseline | 6.62 Units on a Scale | Standard Deviation 3.35 |
| Placebo | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint | Change from Baseline | -1.96 Units on a Scale | Standard Deviation 3.6 |
p-value: 0.06895% CI: [-1.72, 0.06]ANCOVA
Secondary
Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).
Time frame: Baseline, Week 15
Population: Participants with a baseline and at least one post-baseline result within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Overall Pain, Past Week, Baseline | 27.56 Units on a Scale | Standard Deviation 26.05 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Overall Pain, Past Week, Change | -15.28 Units on a Scale | Standard Deviation 26.3 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Headaches, Past Week, Baseline | 21.11 Units on a Scale | Standard Deviation 26.33 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Headaches, Past Week, Change | -9.44 Units on a Scale | Standard Deviation 24.61 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Back Pain, Past Week, Baseline | 18.13 Units on a Scale | Standard Deviation 24.99 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Back Pain, Past Week, Change | -9.40 Units on a Scale | Standard Deviation 21.19 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Shoulder Pain, Past Week, Baseline | 16.53 Units on a Scale | Standard Deviation 23.96 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Shoulder Pain, Past Week, Change | -8.85 Units on a Scale | Standard Deviation 23.55 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Pain Interference, Daily Activities, Baseline | 27.19 Units on a Scale | Standard Deviation 29.26 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Pain Interference, Daily Activities, Change | -16.92 Units on a Scale | Standard Deviation 25.41 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Pain During Waking Hours, Past Week, Baseline | 26.84 Units on a Scale | Standard Deviation -28.48 |
| Duloxetine | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Pain During Waking Hours, Past Week, Change | -16.77 Units on a Scale | Standard Deviation 27.53 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Pain During Waking Hours, Past Week, Baseline | 33.22 Units on a Scale | Standard Deviation 33.44 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Overall Pain, Past Week, Baseline | 31.94 Units on a Scale | Standard Deviation 27.62 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Shoulder Pain, Past Week, Baseline | 19.68 Units on a Scale | Standard Deviation 27.74 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Overall Pain, Past Week, Change | -13.40 Units on a Scale | Standard Deviation 29.42 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Pain Interference, Daily Activities, Change | -12.69 Units on a Scale | Standard Deviation 27.53 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Headaches, Past Week, Baseline | 24.52 Units on a Scale | Standard Deviation 26.68 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Shoulder Pain, Past Week, Change | -8.52 Units on a Scale | Standard Deviation 27.12 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Headaches, Past Week, Change | -10.57 Units on a Scale | Standard Deviation 26.36 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Pain During Waking Hours, Past Week, Change | -14.58 Units on a Scale | Standard Deviation 29.74 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Back Pain, Past Week, Baseline | 17.40 Units on a Scale | Standard Deviation 25.41 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Pain Interference, Daily Activities, Baseline | 26.41 Units on a Scale | Standard Deviation 26.03 |
| Placebo | Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint | Severity of Back Pain, Past Week, Change | -3.36 Units on a Scale | Standard Deviation 26.55 |
p-value: 0.06395% CI: [-10.93, 0.3]ANCOVA
p-value: 0.6695% CI: [-6.64, 4.22]ANCOVA
p-value: 0.02595% CI: [-11.3, -0.76]ANCOVA
p-value: 0.2695% CI: [-8.06, 2.19]ANCOVA
p-value: 0.14595% CI: [-8.61, 1.28]ANCOVA
p-value: 0.01195% CI: [-12.64, -1.66]ANCOVA
Secondary
Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint
Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).
Time frame: Week 15
Population: Participants with at least one post-baseline result within each treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint | 2.08 Units on a Scale | Standard Deviation 0.97 |
| Placebo | Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint | 2.54 Units on a Scale | Standard Deviation 1.2 |
p-value: 0.00495% CI: [-0.74, -0.15]ANOVA