An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Schizophrenia

Treatments: Drug: PF-02545920; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01939548

A8241019

Details and patient eligibility

About

This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 from baseline compared to placebo.

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Psychiatrically stable subjects with schizophrenia who have had a suboptimal response to current treatment
• Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
• Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.

Exclusion criteria

• History of seizures or of a condition with risk of seizures.
• Subjects with schizophrenia that have not responded at all to current treatment.
• Pregnant or nursing females, and females of child bearing potential.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

240 participants in 3 patient groups, including a placebo group

PF-02545920 (5mg)

Experimental group

Treatment:

Drug: PF-02545920

Drug: PF-02545920

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-02545920 (15mg)

Experimental group

Treatment:

Drug: PF-02545920

Drug: PF-02545920