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

NCT ID: NCT01939548

Last Updated: 2016-08-22

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-02545920 (5mg)

Group Type EXPERIMENTAL

PF-02545920

Intervention Type DRUG

PF-02545920 2 mg BID x 7 days, then 5 mg BID until the Week 12 visit

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo BID until the Week 12 visit

PF-02545920 (15mg)

Group Type EXPERIMENTAL

PF-02545920

Intervention Type DRUG

PF-02545920 5 mg BID x 7 days, then 10 mg BID x 7 days, then 15 mg BID until the Week 12 visit

Interventions

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PF-02545920

PF-02545920 2 mg BID x 7 days, then 5 mg BID until the Week 12 visit

Intervention Type DRUG

Placebo

Placebo BID until the Week 12 visit

Intervention Type DRUG

PF-02545920

PF-02545920 5 mg BID x 7 days, then 10 mg BID x 7 days, then 15 mg BID until the Week 12 visit

Intervention Type DRUG

Other Intervention Names

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5 mg BID 15 mg BID

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Birmingham Psychiatry Pharmaceutical Studies, Inc.

Birmingham, Alabama, United States

Site Status

Woodland International Research Group, INC

Little Rock, Arkansas, United States

Site Status

Comprehensive Clinical Development, Inc.

Cerritos, California, United States

Site Status

ProScience Research Group

Culver City, California, United States

Site Status

Synergy Clinical Research of Escondido

Escondido, California, United States

Site Status

Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

Site Status

Pacific Research Partners

Oakland, California, United States

Site Status

Excell Research, Inc.

Oceanside, California, United States

Site Status

Neuropsychiatric Research Center of Orange County

Orange, California, United States

Site Status

CiTrials

Riverside, California, United States

Site Status

CNRI-San Diego, LLC

San Diego, California, United States

Site Status

Sharp Mesa Vista Hospital

San Diego, California, United States

Site Status

Collaborative Neuroscience Network, Inc.

Torrance, California, United States

Site Status

Bliss Basement Pharmacy

Hartford, Connecticut, United States

Site Status

Institute of Living

Hartford, Connecticut, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Comprehensive Clinical Development

Washington D.C., District of Columbia, United States

Site Status

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Site Status

Florida Clinical research Center, LLC

Brandenton, Florida, United States

Site Status

Innovative Clinical Research, Inc.

Lauderhill, Florida, United States

Site Status

Medical Research Group of Central Florida

Sanford, Florida, United States

Site Status

Comprehensive Clinical Development, Inc.

Atlanta, Georgia, United States

Site Status

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, United States

Site Status

Chinmay K. Patel, DO

Hoffman Estates, Illinois, United States

Site Status

Behavioral Health Care Associates

Schaumburg, Illinois, United States

Site Status

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Site Status

Louisiana Clinical Research

Shreveport, Louisiana, United States

Site Status

CBH Health, LLC

Rockville, Maryland, United States

Site Status

Psychiatric Care & Research Center

O'Fallon, Missouri, United States

Site Status

St. Louis Clinical Trials/The Summit@Creve Coeur

St Louis, Missouri, United States

Site Status

Altea Research

Las Vegas, Nevada, United States

Site Status

Comprehensive Clinical Development

Jamaica, New York, United States

Site Status

Manhattan Psychiatric Center's 125th St. Clinic

New York, New York, United States

Site Status

Manhattan Psychiatric Center

Ward's Island, New York, United States

Site Status

Midwest Clinical Research Center, LLC

Dayton, Ohio, United States

Site Status

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Site Status

Research Strategies of Memphis, LLC

Memphis, Tennessee, United States

Site Status

FutureSearch Trials

Austin, Texas, United States

Site Status

Community Clinical Research, Inc

Austin, Texas, United States

Site Status

Futuresearch Trials of Dallas

Dallas, Texas, United States

Site Status

Pillar Clinical Research LLC

Dallas, Texas, United States

Site Status

InSite Clinical Research

DeSoto, Texas, United States

Site Status

Psychiatric and Behaviorial Solutions

Salt Lake City, Utah, United States

Site Status

Lifetree Clinical Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Targum SD, Cara Pendergrass J, Toner C, Zumpano L, Rauh P, DeMartinis N. Impact of BPRS interview length on ratings reliability in a schizophrenia trial. Eur Neuropsychopharmacol. 2015 Mar;25(3):312-8. doi: 10.1016/j.euroneuro.2014.11.023. Epub 2014 Dec 13.

Reference Type DERIVED
PMID: 25554563 (View on PubMed)

Related Links

Other Identifiers

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A8241019

Identifier Type: -

Identifier Source: org_study_id

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