Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

Pfizer

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Other: Placebo; Drug: Aripiprazole; Drug: PF-00217830

Study type: Interventional

Funder types: Industry

Identifiers

NCT00580125

A7251006

Details and patient eligibility

About

The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Key inclusion criteria include:

• Have a current diagnosis of schizophrenia.
• Increase in symptoms over the past 2-4 weeks.
• Willing to remain inpatients for the duration of the trial.

Exclusion criteria

• Subjects with a current DSM-IV axis I diagnosis other than schizophrenia
• Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence
• Subjects with a history of treatment resistant schizophrenia
• Females of childbearing potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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164 participants in 5 patient groups, including a placebo group

A2

Experimental group

Treatment:

Drug: PF-00217830

Drug: PF-00217830

Drug: PF-00217830

A5

Placebo Comparator group

Treatment:

Other: Placebo

A4

Active Comparator group

Treatment:

Drug: Aripiprazole

A3

Experimental group

Treatment:

Drug: PF-00217830

Drug: PF-00217830

Drug: PF-00217830

A1

Experimental group

Treatment:

Drug: PF-00217830

Drug: PF-00217830

Drug: PF-00217830