An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia

Pfizer

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Risperidone; Drug: PF-02545920

Study type: Interventional

Funder types: Industry

Identifiers

NCT01175135

2010-020764-38 (EudraCT Number)

A8241012

Details and patient eligibility

About

This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 compared to risperidone and placebo treatment.

Enrollment: 259 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia with acute exacerbation of illness
• The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.

Exclusion criteria

• Subjects with evidence or history of clinically significant uncontrolled medical illness
• Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
• Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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259 participants in 4 patient groups, including a placebo group

PF-02545920 5 mg

Experimental group

Treatment:

Drug: PF-02545920

Drug: PF-02545920

PF-02545920 15 mg

Experimental group

Treatment:

Drug: PF-02545920

Drug: PF-02545920

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Risperidone 3 mg

Active Comparator group

Treatment:

Drug: Risperidone