Schizophrenia
Conditions
Brief summary
To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)
Detailed description
The study consists of a Screening Period (3 weeks), a single-blind Prospective Confirmation (PC) Period (6 weeks), a Double-blind Treatment (DBT) Period (10 weeks), and a Safety Follow-up Period (6 weeks). Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period. Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period and were randomized into one of 3 treatment arms (1:1:1) with either Lu AF35700 10 mg/day, Lu AF35700 20 mg/day or to continue the treatment allocated in PC Period (olanzapine or risperidone) at the dose set at last visit of PC Period. This mean that approximately one third of the confirmed treatment-resistant patients were randomised back to the failed treatment used in the PC Period. Data was not collected separately for the DBT Olanzapine and DBT Risperidone participants, and there was no intent to compare Lu AF35700 to each drug separately.
Interventions
DRUGRisperidone
4-6 mg/day, encapsulated tablets, orally
DRUGOlanzapine
15-20 mg/day, encapsulated tablets, orally
DRUGLu AF35700
10 mg/day, encapsulated tablets, orally
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders * The patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist. * Patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to Screening * The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to Screening. The failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s) * The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the following PANSS items (at Screening and at the first visit of Period A) * The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A
Exclusion criteria
* The patient has any current primary psychiatric disorder other than schizophrenia as assessed by the Mini International Neuropsychiatric Interview (MINI) * The patient is experiencing an acute exacerbation of his/her psychotic symptoms * The patient has not responded to treatment with clozapine Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score | From Randomization to Week 10 | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score | From Randomization to Week 10 | CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening. |
| Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4 | From Randomization to Week 10 | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. The Clinical Global Impression scale - severity of illness (CGI-S) is administered by the investigator. The patient is rated on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). A reduction in scale indicates improvement. |
| Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | From Randomization to Week 10 | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. |
| Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score | From Randomization to Week 10 | PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. It consists of 4 items: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviours. Each items were assessed on a 6-point scale, from 1 (absent) to 6 (very severe). PSP score was calculated as sum of all the items on the scale and ranged from 4 to 100. A higher score represents more severe functional impairment. |
| Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | From Randomization to Week 10 | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. |
| Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | From Randomization to Week 10 | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. |
| Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization | From Randomization to Week 10 | Positive and Negative Syndrome Scale (PANSS) total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. |
Countries
Bulgaria, Canada, Czechia, Estonia, Finland, Mexico, Poland, Romania, Russia, Serbia, Slovakia, Spain, Ukraine, United States
Participant flow
Pre-assignment details
Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period. Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment.
Participants by arm
| Arm | Count |
|---|---|
| Non-randomized Patients Patients not randomized into the double-blind treatment period, i.e. withdrawn from the study during or after the PC period, were analyzed as one arm independent of treatment. | 401 |
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks | 235 |
| DBT Period, Lu AF35700 20 mg Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks | 232 |
| DBT Period, Continued Treatment From PC Period Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. | 230 |
| Total | 1,098 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-blind Treatment (DBT) Period | Adverse Event | 0 | 0 | 10 | 11 | 8 |
| Double-blind Treatment (DBT) Period | Change of residence | 0 | 0 | 0 | 1 | 1 |
| Double-blind Treatment (DBT) Period | Enrolled but not treated | 0 | 0 | 1 | 0 | 0 |
| Double-blind Treatment (DBT) Period | Family circumstances | 0 | 0 | 0 | 0 | 1 |
| Double-blind Treatment (DBT) Period | Investigator decision | 0 | 0 | 0 | 1 | 1 |
| Double-blind Treatment (DBT) Period | Lack of Efficacy | 0 | 0 | 6 | 9 | 2 |
| Double-blind Treatment (DBT) Period | Lost to Follow-up | 0 | 0 | 0 | 3 | 2 |
| Double-blind Treatment (DBT) Period | Needed antidepressant medication | 0 | 0 | 0 | 0 | 1 |
| Double-blind Treatment (DBT) Period | Non-compliance with IMP | 0 | 0 | 4 | 3 | 2 |
| Double-blind Treatment (DBT) Period | Patient decision | 0 | 0 | 0 | 2 | 2 |
| Double-blind Treatment (DBT) Period | Patient missed required visits | 0 | 0 | 0 | 1 | 1 |
| Double-blind Treatment (DBT) Period | Protocol Violation | 0 | 0 | 1 | 0 | 1 |
| Double-blind Treatment (DBT) Period | Psychosocial issues | 0 | 0 | 1 | 0 | 0 |
| Double-blind Treatment (DBT) Period | Withdrawal by Subject | 0 | 0 | 14 | 13 | 8 |
| Prospective Confirmation (PC) Period | Adverse Event | 19 | 7 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Apato Abulcasis Syndrome | 0 | 1 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Change of place of residence | 1 | 0 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Did not fulfill rand criteria for DBT | 189 | 75 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Duplicate subject | 1 | 0 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Enrolled but not treated | 3 | 3 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Investigator decision | 2 | 1 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Lack of Efficacy | 2 | 1 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Lack of results for blood levels | 1 | 0 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Lost to Follow-up | 9 | 4 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Low level of drug in the blood | 1 | 0 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Non-compliance with IMP | 7 | 1 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Noncompliance with protocol | 1 | 0 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Patient decision | 5 | 2 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Patient fraud with payment | 1 | 0 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Positive Urine Drug Screen | 0 | 1 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Protocol Violation | 3 | 1 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Sponsor requested | 0 | 1 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Subject took exclusionary medication | 0 | 1 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Sub therapeutic blood levels Olanzapine | 1 | 0 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Technical error | 1 | 0 | 0 | 0 | 0 |
| Prospective Confirmation (PC) Period | Withdrawal by Subject | 43 | 12 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Non-randomized Patients | Total | DBT Period, Continued Treatment From PC Period | DBT Period, Lu AF35700 20 mg | Double-blind Treatment (DBT) Period, Lu AF35700 10 mg |
|---|---|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 11.05 | 43 years STANDARD_DEVIATION 11.41 | 43.2 years STANDARD_DEVIATION 11.19 | 42.3 years STANDARD_DEVIATION 11.44 | 42.6 years STANDARD_DEVIATION 12.14 |
| CGI-S score | 4.82 units on a scale STANDARD_DEVIATION 0.6 | 4.89 units on a scale STANDARD_DEVIATION 0.58 | 4.90 units on a scale STANDARD_DEVIATION 0.53 | 5.00 units on a scale STANDARD_DEVIATION 0.57 | 4.88 units on a scale STANDARD_DEVIATION 0.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 59 Participants | 8 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 224 Participants | 357 Participants | 45 Participants | 42 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 142 Participants | 682 Participants | 177 Participants | 180 Participants | 183 Participants |
| PANSS total score | 97.25 units on a scale STANDARD_DEVIATION 11.21 | 97.6 units on a scale STANDARD_DEVIATION 10.12 | 98.40 units on a scale STANDARD_DEVIATION 9.84 | 98.23 units on a scale STANDARD_DEVIATION 9.29 | 96.96 units on a scale STANDARD_DEVIATION 9.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 172 Participants | 275 Participants | 34 Participants | 33 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 36 Participants | 94 Participants | 17 Participants | 19 Participants | 22 Participants |
| Race (NIH/OMB) White | 186 Participants | 719 Participants | 178 Participants | 179 Participants | 176 Participants |
| Sex: Female, Male Female | 147 Participants | 421 Participants | 89 Participants | 94 Participants | 91 Participants |
| Sex: Female, Male Male | 254 Participants | 677 Participants | 141 Participants | 138 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 708 | 0 / 384 | 0 / 234 | 0 / 232 | 1 / 230 |
| other Total, other adverse events | 60 / 708 | 45 / 384 | 20 / 235 | 40 / 232 | 25 / 230 |
| serious Total, serious adverse events | 14 / 708 | 7 / 384 | 6 / 234 | 5 / 232 | 5 / 230 |
Outcome results
Primary
Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia.
Time frame: From Randomization to Week 10
Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score | -10.01 units on a scale | Standard Error 0.96 |
| DBT Period, Lu AF35700 20 mg | Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score | -8.22 units on a scale | Standard Error 0.98 |
| DBT Period, Continued Treatment From PC Period | Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score | -9.90 units on a scale | Standard Error 0.97 |
Comparison: The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.p-value: 0.919695% CI: [-2.37, 2.13]Mixed model repeated measures
Comparison: The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.p-value: 0.147495% CI: [-0.59, 3.94]Mixed model repeated measures
Secondary
Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score
CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening.
Time frame: From Randomization to Week 10
Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score | -0.59 units on a scale | Standard Error 0.06 |
| DBT Period, Lu AF35700 20 mg | Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score | -0.54 units on a scale | Standard Error 0.06 |
| DBT Period, Continued Treatment From PC Period | Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score | -0.57 units on a scale | Standard Error 0.06 |
Secondary
Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score
PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. It consists of 4 items: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviours. Each items were assessed on a 6-point scale, from 1 (absent) to 6 (very severe). PSP score was calculated as sum of all the items on the scale and ranged from 4 to 100. A higher score represents more severe functional impairment.
Time frame: From Randomization to Week 10
Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score | 4.90 units on a scale | Standard Error 0.96 |
| DBT Period, Lu AF35700 20 mg | Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score | 3.23 units on a scale | Standard Error 0.98 |
| DBT Period, Continued Treatment From PC Period | Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score | 3.94 units on a scale | Standard Error 0.98 |
Comparison: The mean changes from Randomization in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.p-value: 0.299895% CI: [-0.86, 2.78]Mixed model repeated measures
Comparison: The mean changes in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.p-value: 0.447895% CI: [-2.54, 1.12]Mixed model repeated measures
Secondary
Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. The Clinical Global Impression scale - severity of illness (CGI-S) is administered by the investigator. The patient is rated on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). A reduction in scale indicates improvement.
Time frame: From Randomization to Week 10
Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4 | 21 Participants |
| DBT Period, Lu AF35700 20 mg | Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4 | 18 Participants |
| DBT Period, Continued Treatment From PC Period | Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4 | 12 Participants |
Secondary
Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.
Time frame: From Randomization to Week 10
Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | 82 Participants |
| DBT Period, Lu AF35700 20 mg | Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | 59 Participants |
| DBT Period, Continued Treatment From PC Period | Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | 77 Participants |
Secondary
Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization
Positive and Negative Syndrome Scale (PANSS) total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.
Time frame: From Randomization to Week 10
Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization | 42 Participants |
| DBT Period, Lu AF35700 20 mg | Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization | 30 Participants |
| DBT Period, Continued Treatment From PC Period | Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization | 45 Participants |
Secondary
Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.
Time frame: From Randomization to Week 10
Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | 23 Participants |
| DBT Period, Lu AF35700 20 mg | Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | 15 Participants |
| DBT Period, Continued Treatment From PC Period | Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | 16 Participants |
Secondary
Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.
Time frame: From Randomization to Week 10
Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | 10 Participants |
| DBT Period, Lu AF35700 20 mg | Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | 4 Participants |
| DBT Period, Continued Treatment From PC Period | Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | 6 Participants |