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

Wyeth

Status and phase: Withdrawn; Phase 2

Conditions: Schizophrenia

Treatments: Drug: SCA-136 300mg/day; Drug: SCA-136 150 mg/day; Drug: Risperidone 4mg/day; Drug: SCA-136 50mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768612

3153B1-2208

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

1

Experimental group

Description:

Lowest dose

Treatment:

Drug: SCA-136 50mg/day

2

Experimental group

Description:

Middle dose

Treatment:

Drug: SCA-136 150 mg/day

3

Experimental group

Description:

Highest dose

Treatment:

Drug: SCA-136 300mg/day

4

Active Comparator group

Description:

Positive Control

Treatment:

Drug: Risperidone 4mg/day