Study Evaluating Vabicaserin in Subjects With Schizophrenia

Pfizer

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: vabicaserin; Other: placebo; Drug: risperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00563706

3153A1-2203

B1911032

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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199 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: vabicaserin

2

Active Comparator group

Description:

4mg/day

Treatment:

Drug: risperidone

3

Placebo Comparator group

Description:

matching placebo

Treatment:

Other: placebo