Schizophrenia
Conditions
Brief summary
The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.
Interventions
DRUGvabicaserin
This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
DRUGrisperidone
OTHERplacebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Generally healthy, men and women, aged 18 to 65. * Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year. * Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.
Exclusion criteria
* Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria). * Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1). * Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | Baseline | PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. |
| Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | Baseline, Day 28 | PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score | Baseline, Day 7, 14, 21, 28 | General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity. |
| Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score | Baseline, Day 7, 14, 21, 28 | Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity. |
| Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score | Baseline, Day 7, 14, 21, 28 | Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. |
| Positive and Negative Symptom Scale (PANSS) Positive Subscale Score | Baseline, Day 7, 14, 21, 28 | PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity. |
| Clinical Global Impression - Improvement (CGI-I) Score | Day 7, 14, 21, 28 | CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse). |
| Calgary Depression Scale for Schizophrenia (CDSS) Score | Baseline, Day 7, 14, 21, 28 | CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms. |
| Clinical Global Impression - Severity (CGI-S) Score | Baseline, Day 7, 14, 21, 28 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). |
| Positive and Negative Symptom Scale (PANSS) Negative Subscale Score | Baseline, Day 7, 14, 21, 28 | PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity. |
Countries
Canada, United States
Participant flow
Pre-assignment details
A total of 204 participants were randomized, of which 202 participants received at least 1 dose of double-blind test article.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. | 37 |
| Vabicaserin 50 mg One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. | 18 |
| Vabicaserin 100 mg One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. | 8 |
| Vabicaserin 150 mg One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. | 19 |
| Vabicaserin 200 mg Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. | 16 |
| Vabicaserin 300 mg Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. | 19 |
| Vabicaserin 400 mg Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. | 12 |
| Vabicaserin 600 mg Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. | 30 |
| Risperidone One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase. | 43 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| DB Treatment Period (Day 1 up to Day 28) | Adverse Event | 4 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 5 |
| DB Treatment Period (Day 1 up to Day 28) | Discontinuation of Study by Sponsor | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| DB Treatment Period (Day 1 up to Day 28) | Lack of Efficacy | 2 | 1 | 2 | 4 | 1 | 2 | 2 | 5 | 1 |
| DB Treatment Period (Day 1 up to Day 28) | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| DB Treatment Period (Day 1 up to Day 28) | Withdrawal by Subject | 9 | 3 | 2 | 5 | 4 | 3 | 1 | 6 | 3 |
Baseline characteristics
| Characteristic | Placebo | Vabicaserin 50 mg | Vabicaserin 100 mg | Vabicaserin 150 mg | Vabicaserin 200 mg | Vabicaserin 300 mg | Vabicaserin 400 mg | Vabicaserin 600 mg | Risperidone | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.05 years STANDARD_DEVIATION 9.88 | 43.22 years STANDARD_DEVIATION 10.17 | 41.25 years STANDARD_DEVIATION 4.89 | 40.53 years STANDARD_DEVIATION 11.43 | 42.94 years STANDARD_DEVIATION 8.27 | 40.74 years STANDARD_DEVIATION 10.29 | 38.17 years STANDARD_DEVIATION 9.73 | 43.60 years STANDARD_DEVIATION 9.25 | 42.72 years STANDARD_DEVIATION 9.93 | 42.07 years STANDARD_DEVIATION 9.67 |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 1 Participants | 4 Participants | 5 Participants | 3 Participants | 0 Participants | 6 Participants | 10 Participants | 41 Participants |
| Sex: Female, Male Male | 29 Participants | 14 Participants | 7 Participants | 15 Participants | 11 Participants | 16 Participants | 12 Participants | 24 Participants | 33 Participants | 161 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 | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 37 | 12 / 18 | 6 / 8 | 11 / 19 | 13 / 16 | 13 / 19 | 10 / 12 | 23 / 30 | 35 / 43 |
| serious Total, serious adverse events | 4 / 37 | 0 / 18 | 1 / 8 | 0 / 19 | 0 / 16 | 1 / 19 | 2 / 12 | 2 / 30 | 3 / 43 |
Outcome results
Primary
Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Time frame: Baseline, Day 28
Population: mITT population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | -17.03 units on a scale | Standard Error 3.59 |
| Vabicaserin 50 mg | Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | -4.72 units on a scale | Standard Error 4.87 |
| Vabicaserin 100 mg | Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | -10.26 units on a scale | Standard Error 8.35 |
| Vabicaserin 150 mg | Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | -5.41 units on a scale | Standard Error 5.18 |
| Vabicaserin 200 mg | Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | -13.42 units on a scale | Standard Error 5.17 |
| Vabicaserin 300 mg | Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | -6.13 units on a scale | Standard Error 4.8 |
| Vabicaserin 400 mg | Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | -13.84 units on a scale | Standard Error 5.93 |
| Vabicaserin 600 mg | Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | -7.30 units on a scale | Standard Error 4.09 |
| Risperidone | Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 | -15.59 units on a scale | Standard Error 3.2 |
Comparison: Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.p-value: 0.04395% CI: [-24.24, -0.37]Mixed Models Analysis
Comparison: Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.p-value: 0.45795% CI: [-24.7, 11.16]Mixed Models Analysis
Comparison: Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.p-value: 0.06795% CI: [-24.03, 0.81]Mixed Models Analysis
Comparison: Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.p-value: 0.56795% CI: [-16.02, 8.8]Mixed Models Analysis
Comparison: Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.p-value: 0.0795% CI: [-22.71, 0.92]Mixed Models Analysis
Comparison: Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.p-value: 0.64795% CI: [-16.87, 10.5]Mixed Models Analysis
Comparison: Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.p-value: 0.07595% CI: [-20.46, 1]Mixed Models Analysis
Comparison: Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.p-value: 0.76595% CI: [-10.92, 8.04]Mixed Models Analysis
Primary
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Time frame: Baseline
Population: Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | 94.74 units on a scale | Standard Deviation 11.18 |
| Vabicaserin 50 mg | Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | 94.24 units on a scale | Standard Deviation 8.42 |
| Vabicaserin 100 mg | Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | 96.88 units on a scale | Standard Deviation 14.54 |
| Vabicaserin 150 mg | Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | 101.33 units on a scale | Standard Deviation 12.97 |
| Vabicaserin 200 mg | Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | 93.06 units on a scale | Standard Deviation 8.84 |
| Vabicaserin 300 mg | Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | 94.39 units on a scale | Standard Deviation 8.73 |
| Vabicaserin 400 mg | Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | 92.83 units on a scale | Standard Deviation 10.25 |
| Vabicaserin 600 mg | Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | 95.54 units on a scale | Standard Deviation 12.46 |
| Risperidone | Positive and Negative Symptom Scale (PANSS) Total Score at Baseline | 91.43 units on a scale | Standard Deviation 10.83 |
Secondary
Calgary Depression Scale for Schizophrenia (CDSS) Score
CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.
Time frame: Baseline, Day 7, 14, 21, 28
Population: Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Secondary
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).
Time frame: Day 7, 14, 21, 28
Population: Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Secondary
Clinical Global Impression - Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Time frame: Baseline, Day 7, 14, 21, 28
Population: Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Secondary
Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score
Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Time frame: Baseline, Day 7, 14, 21, 28
Population: Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Secondary
Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score
Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.
Time frame: Baseline, Day 7, 14, 21, 28
Population: Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Secondary
Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score
General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.
Time frame: Baseline, Day 7, 14, 21, 28
Population: Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Secondary
Positive and Negative Symptom Scale (PANSS) Negative Subscale Score
PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.
Time frame: Baseline, Day 7, 14, 21, 28
Population: Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Secondary
Positive and Negative Symptom Scale (PANSS) Positive Subscale Score
PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.
Time frame: Baseline, Day 7, 14, 21, 28
Population: Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.