A Randomized, Double-Blind, Placebo-Controlled, Risperidone-Referenced, Parallel-Group, Adaptive-Design Study of the Efficacy, Safety, and Tolerability of Vabicaserin (SCA-136) in Subjects With Acute Exacerbations of Schizophrenia
Overview
- Phase
- Phase 2
- Intervention
- vabicaserin
- Conditions
- Schizophrenia
- Sponsor
- Pfizer
- Enrollment
- 199
- Locations
- 1
- Primary Endpoint
- Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Generally healthy, men and women, aged 18 to
- •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.
Arms & Interventions
1
Intervention: vabicaserin
2
4mg/day
Intervention: risperidone
3
matching placebo
Intervention: placebo
Outcomes
Primary Outcomes
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
Time Frame: 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
Time Frame: 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 Outcomes
- Positive and Negative Symptom Scale (PANSS) Positive Subscale Score(Baseline, Day 7, 14, 21, 28)
- Positive and Negative Symptom Scale (PANSS) Negative Subscale Score(Baseline, Day 7, 14, 21, 28)
- Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score(Baseline, Day 7, 14, 21, 28)
- Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score(Baseline, Day 7, 14, 21, 28)
- Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score(Baseline, Day 7, 14, 21, 28)
- Clinical Global Impression - Severity (CGI-S) Score(Baseline, Day 7, 14, 21, 28)
- Clinical Global Impression - Improvement (CGI-I) Score(Day 7, 14, 21, 28)
- Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline, Day 7, 14, 21, 28)