Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia

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Overview

This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Schizophrenia

Interventions

SCA-136 50mg/dayDRUG

SCA-136 150 mg/dayDRUG

SCA-136 300mg/dayDRUG

Risperidone 4mg/dayDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects between \>=20 and =\<65 years of age * Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90) * Total PANSS score \>=70 and =\< 120 Exclusion Criteria: * Subjects who are hospitalized against their will * Current Axis I primary psychiatric diagnosis other than schizophrenia * A score of 3 on CDSS question 8 which pertains to suicide

Outcomes

Primary Outcomes

Positive and Negative Syndrome Scale PANSS

Time frame: 6 week

Secondary Outcomes

Calgary Depression Scale for Schizophrenia CDSS

Time frame: 6 week

Data from ClinicalTrials.gov

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