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

Schizophrenia Clinical Trial

Official title:

A 12-week , Randomized, Phase 2, Double-blind, Parallel-group Study Of Two Dose Levels Of Pf-02545920 Compared To Placebo In The Adjunctive Treatment Of Outpatients With Sub-optimally Controlled Symptoms Of Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01939548
• Other study ID #: A8241019
• Status: Terminated
• Phase: Phase 2
• First received: August 9, 2013
• Last updated: January 8, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	Comprehensive Clinical Development, Inc.	Atlanta	Georgia
United States	Community Clinical Research, Inc	Austin	Texas
United States	FutureSearch Trials	Austin	Texas
United States	Birmingham Psychiatry Pharmaceutical Studies, Inc.	Birmingham	Alabama
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Comprehensive Clinical Development, Inc.	Cerritos	California
United States	ProScience Research Group	Culver City	California
United States	Futuresearch Trials of Dallas	Dallas	Texas
United States	Pillar Clinical Research LLC	Dallas	Texas
United States	Midwest Clinical Research Center, LLC	Dayton	Ohio
United States	InSite Clinical Research	DeSoto	Texas
United States	Synergy Clinical Research of Escondido	Escondido	California
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Bliss Basement Pharmacy	Hartford	Connecticut
United States	Institute of Living	Hartford	Connecticut
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Chinmay K. Patel, DO	Hoffman Estates	Illinois
United States	Comprehensive Clinical Development	Jamaica	New York
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Altea Research	Las Vegas	Nevada
United States	Innovative Clinical Research, Inc.	Lauderhill	Florida
United States	Woodland International Research Group, INC	Little Rock	Arkansas
United States	Research Strategies of Memphis, LLC	Memphis	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Manhattan Psychiatric Center's 125th St. Clinic	New York	New York
United States	Psychiatric Care & Research Center	O'Fallon	Missouri
United States	Pacific Research Partners	Oakland	California
United States	Excell Research, Inc.	Oceanside	California
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	Neuropsychiatric Research Center of Orange County	Orange	California
United States	Clinical Innovations, Inc.	Riverside	California
United States	CBH Health, LLC	Rockville	Maryland
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	Psychiatric and Behaviorial Solutions	Salt Lake City	Utah
United States	CNRI-San Diego, LLC	San Diego	California
United States	Sharp Mesa Vista Hospital	San Diego	California
United States	Medical Research Group of Central Florida	Sanford	Florida
United States	Behavioral Health Care Associates	Schaumburg	Illinois
United States	Louisiana Clinical Research	Shreveport	Louisiana
United States	St. Louis Clinical Trials/The Summitt@Creve Coeur	St. Louis	Missouri
United States	Collaborative Neuroscience Network, Inc.	Torrance	California
United States	Manhattan Psychiatric Center	Ward's Island	New York
United States	Comprehensive Clinical Development	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 12 in PANSS Total		Baseline to Week 12	No
Secondary	Change from Baseline to Week 12 on the individual domain scores and clinical global impression scores on the abbreviated version of the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)		Baseline to Week 12	Yes
Secondary	The Columbia Suicide Severity Rating Scale (C SSRS)		Screening up to Day 110	Yes
Secondary	Incidence rate of extrapyramidal motor system AEs (eg, dystonia, akathisia)		Baseline to Week 12	Yes
Secondary	Fasting insulin (Baseline, Week 6, and Week 12), HDL, LDL, Cholesterol, Triglycerides, HbA1c and serum prolactin		Baseline to Week 12	Yes
Secondary	Change from Baseline to Week 12 on the Movement Disorder Burden Score-Dystonia (MDBS-D)		Baseline to Week 12	Yes
Secondary	Change from Baseline to Week 12 in Personal and Social Performance scale (PSP)		Baseline to Week 12	No
Secondary	Change from Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) subscales and derived scales		Baseline to Week 12	No
Secondary	Change from Baseline to Week 12 in the Clinical Global Impression Severity Scale		Baseline to Week 12	No
Secondary	Total score at Week 12 on the Clinical Global Impression Improvement Scale		Baseline to Week 12	No

External Links

•   To obtain contact information for a study center near you, click here.