Phase 2
Completed N=202
Study Evaluating Vabicaserin in Subjects With Schizophrenia
Source: ClinicalTrials.gov NCT00563706 ↗Enrolled (actual)
202
Serious AEs
6.4%
Results posted
Mar 2014
Primary outcomePrimary: Positive and Negative Symptom Scale (PANSS) Total Score at Baseline — 94.74; 94.24; 96.88; 101.33 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive and Negative Symptom Scale (PANSS) Total Score at Baseline |
94.74; 94.24; 96.88; 101.33; 93.06; 94.39 | — |
| PRIMARY Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 |
-17.03; -4.72; -10.26; -5.41; -13.42; -6.13 | 0.043 sig |
| SECONDARY Positive and Negative Symptom Scale (PANSS) Positive Subscale Score |
— | — |
| SECONDARY Positive and Negative Symptom Scale (PANSS) Negative Subscale Score |
— | — |
| SECONDARY Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score |
— | — |
| SECONDARY Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score |
— | — |
| SECONDARY Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score |
— | — |
| SECONDARY Clinical Global Impression - Severity (CGI-S) Score |
— | — |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) Score |
— | — |
| SECONDARY Calgary Depression Scale for Schizophrenia (CDSS) Score |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00563706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.