Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

Wyeth is now a wholly owned subsidiary of Pfizer300 enrolled

Overview

The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Schizophrenia

Interventions

SCA-136 (200 mg)DRUG

SCA-136 (400 mg)DRUG

olanzapine (15 mg)DRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of schizophrenia * Ability to remain hospitalized for at least first 4 weeks of study * Needs hospitalization due to worsening of schizophrenia Exclusion Criteria: * Type 1 or 2 diabetes * Previous use of clozapine * Serious medical illness other than schizophrenia

Locations (35)

Outcomes

Primary Outcomes

Change from baseline to day 42 on the positive subscale of the SCI-PANNS

Secondary Outcomes

Change from baseline to day 42 on:

SCI-PANNS total score

negative symptom sub-scale score of SCI-PANNS

general psychopathology subscale score of SCI-PANNS

response rate based upon SCI-PANNS total score

BPRS score

CGI-S score

CGI-I score

Cognitive assessments scores

Data from ClinicalTrials.gov

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