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

Phase 2

Withdrawn

• Conditions: Schizophrenia
• Interventions: Drug: SCA-136 300mg/day; Drug: Risperidone 4mg/day; Drug: SCA-136 150 mg/day; Drug: SCA-136 50mg/day

• Registration Number: NCT00768612
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Study Start: 2008-11
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	SCA-136 300mg/day	Highest dose
4	Risperidone 4mg/day	Positive Control
2	SCA-136 150 mg/day	Middle dose
1	SCA-136 50mg/day	Lowest dose

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale PANSS	6 week

Secondary Outcome Measures

Name	Time	Method
Calgary Depression Scale for Schizophrenia CDSS	6 week