Study Evaluating Vabicaserin in Subjects With Schizophrenia

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Risperidone

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.