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

A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00768612

Enrollment

Registered

2008-10-08

Start date

2008-11-30

Completion date

2009-07-31

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Acute, Schizophrenia, Phase2a, Vabicaserin

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.

Interventions

DRUGSCA-136 50mg/day

DRUGSCA-136 150 mg/day

DRUGSCA-136 300mg/day

DRUGRisperidone 4mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Positive and Negative Syndrome Scale PANSS	6 week

Secondary

Measure	Time frame
Calgary Depression Scale for Schizophrenia CDSS	6 week

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026