Conditions: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 199
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: None arm 2: 4mg/day arm 3: matching placebo

Interventions: intervention 1: vabicaserin intervention 2: risperidone intervention 3: placebo
Intervention descriptions: intervention 1: 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 intervention 2: None intervention 3: None

Protocol document: