Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: PF-02545920

Study type: Interventional

Funder types: Industry

Identifiers

NCT00570063

A8241006

Details and patient eligibility

About

To assess the efficacy and safety of an investigational compound PF-02545920 for the treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.

Enrollment: 35 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Evidence or history of clinically significant medical problems.
2. Females of childbearing potential.
3. A primary psychiatric diagnosis other than schizophrenia.
4. A diagnosis of substance abuse or dependence in the last 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

PF-02545920 15 mg tablets taken twice a day by mouth for 21 days

Treatment:

Drug: PF-02545920

2

Placebo Comparator group

Description:

Matching placebo tablets taken twice a day by mouth for 21 days

Treatment:

Drug: Placebo