Clinical trial NCT01939548: An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: PF-02545920
schizophrenia
outpatient
safety
efficacy
suboptimal response
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline
timeFrame: Baseline
measure: Change From Baseline to Week 12 in PANSS Total Score
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline, Week 12
measure: Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12
timeFrame: Week 12
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
timeFrame: Baseline up to 7-10 days after last dose of study drug (follow-up)
measure: Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
timeFrame: Screening up to 7-10 days after last dose of study drug (follow-up)
measure: Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
timeFrame: Screening/Baseline up to Week 12 (or Early Termination)
measure: Number of Participants With Weight Change >=7%
timeFrame: Screening up to Day 84
measure: Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site
timeFrame: Baseline and Week 12 or Early Termination
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Screening up to Week 12/Early Termination and 7-10 days after last dose of study drug (hematology only)
measure: Number of Participants With Extrapyramidal Motor System (EPS) AEs
timeFrame: Baseline up to 7-10 days after last dose of study drug (follow-up)
measure: Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12
timeFrame: Baseline; Weeks 6 and 12
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12
timeFrame: Baseline; Weeks 6 and 12
measure: Change From Baseline in Insulin at Weeks 6 and 12
timeFrame: Baseline; Weeks 6 and 12
measure: Change From Baseline in Prolactin at Weeks 6 and 12
timeFrame: Baseline; Weeks 6 and 12
measure: Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)
timeFrame: Baseline, Week 12
measure: Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period
timeFrame: Active treatment period (Weeks 1 to 12/Early Termination)
measure: Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline up to 7-10 days after last dose of study drug
measure: Concentration of PF-02545920 and Its Metabolite, PF-01001252
timeFrame: Days 14, 28, 42, 56, 70, 84/Early Termination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.
state: Alabama
city: Little Rock
country: United States
facility: Woodland International Research Group, INC
state: Arkansas
city: Cerritos
country: United States
facility: Comprehensive Clinical Development, Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research of Escondido
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Riverside
country: United States
facility: CiTrials
state: California
city: San Diego
country: United States
facility: CNRI-San Diego, LLC
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Hartford
country: United States
facility: Bliss Basement Pharmacy
state: Connecticut
city: Hartford
country: United States
facility: Institute of Living
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Comprehensive Clinical Development
state: District of Columbia
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Brandenton
country: United States
facility: Florida Clinical research Center, LLC
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Sanford
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Atlanta
country: United States
facility: Comprehensive Clinical Development, Inc.
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Hoffman Estates
country: United States
facility: Chinmay K. Patel, DO
state: Illinois
city: Schaumburg
country: United States
facility: Behavioral Health Care Associates
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Clinical Research
state: Louisiana
city: Rockville
country: United States
facility: CBH Health, LLC
state: Maryland
city: O'Fallon
country: United States
facility: Psychiatric Care & Research Center
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Clinical Trials/The Summit@Creve Coeur
state: Missouri
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Jamaica
country: United States
facility: Comprehensive Clinical Development
state: New York
city: New York
country: United States
facility: Manhattan Psychiatric Center's 125th St. Clinic
state: New York
city: Ward's Island
country: United States
facility: Manhattan Psychiatric Center
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Austin
country: United States
facility: Community Clinical Research, Inc
state: Texas
city: Dallas
country: United States
facility: Futuresearch Trials of Dallas
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research LLC
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Psychiatric and Behaviorial Solutions
state: Utah
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.