Study Stopped
A pre-planned interim analysis indicated the trial was unlikely to meet the pre-specified efficacy criteria. The decision was not based on any safety concerns.
An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
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
1 other identifier
interventional
240
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Oct 2013
Shorter than P25 for phase_2 schizophrenia
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
August 22, 2016
CompletedAugust 22, 2016
July 1, 2016
1 year
August 9, 2013
October 16, 2015
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline
The Positive and Negative Syndrome Scale (PANSS) assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.
Baseline
Change From Baseline to Week 12 in PANSS Total Score
The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.
Baseline, Week 12
Secondary Outcomes (20)
Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score
Baseline, Week 12
Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales
Baseline, Week 12
Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores
Baseline, Week 12
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
Baseline, Week 12
Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12
Week 12
- +15 more secondary outcomes
Study Arms (3)
PF-02545920 (5mg)
EXPERIMENTALPlacebo
PLACEBO COMPARATORPF-02545920 (15mg)
EXPERIMENTALInterventions
PF-02545920 2 mg BID x 7 days, then 5 mg BID until the Week 12 visit
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (44)
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226, United States
Woodland International Research Group, INC
Little Rock, Arkansas, 72211, United States
Comprehensive Clinical Development, Inc.
Cerritos, California, 90703, United States
ProScience Research Group
Culver City, California, 90230, United States
Synergy Clinical Research of Escondido
Escondido, California, 92025, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Pacific Research Partners
Oakland, California, 94612, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
Neuropsychiatric Research Center of Orange County
Orange, California, 92868, United States
CiTrials
Riverside, California, 92506, United States
CNRI-San Diego, LLC
San Diego, California, 92102, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
Collaborative Neuroscience Network, Inc.
Torrance, California, 90502, United States
Bliss Basement Pharmacy
Hartford, Connecticut, 06102, United States
Institute of Living
Hartford, Connecticut, 06106, United States
Yale University
New Haven, Connecticut, 06519, United States
Comprehensive Clinical Development
Washington D.C., District of Columbia, 20016, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208, United States
Florida Clinical research Center, LLC
Brandenton, Florida, 34201, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Medical Research Group of Central Florida
Sanford, Florida, 32771, United States
Comprehensive Clinical Development, Inc.
Atlanta, Georgia, 30328, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
Chinmay K. Patel, DO
Hoffman Estates, Illinois, 60169, United States
Behavioral Health Care Associates
Schaumburg, Illinois, 60194, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629, United States
Louisiana Clinical Research
Shreveport, Louisiana, 71101, United States
CBH Health, LLC
Rockville, Maryland, 20850, United States
Psychiatric Care & Research Center
O'Fallon, Missouri, 63368, United States
St. Louis Clinical Trials/The Summit@Creve Coeur
St Louis, Missouri, 63141, United States
Altea Research
Las Vegas, Nevada, 89102, United States
Comprehensive Clinical Development
Jamaica, New York, 11432, United States
Manhattan Psychiatric Center's 125th St. Clinic
New York, New York, 10027, United States
Manhattan Psychiatric Center
Ward's Island, New York, 10035, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, 45417, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119, United States
FutureSearch Trials
Austin, Texas, 78731, United States
Community Clinical Research, Inc
Austin, Texas, 78754, United States
Futuresearch Trials of Dallas
Dallas, Texas, 75231, United States
Pillar Clinical Research LLC
Dallas, Texas, 75243, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Psychiatric and Behaviorial Solutions
Salt Lake City, Utah, 84105, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Related Publications (1)
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.
PMID: 25554563DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated prematurely as a pre-planned interim analysis indicated the study was unlikely to meet the pre-specified efficacy criteria. The decision was not based on any safety concerns.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2013
First Posted
September 11, 2013
Study Start
October 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
August 22, 2016
Results First Posted
August 22, 2016
Record last verified: 2016-07