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A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia

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ClinicalTrials.gov Identifier: NCT00977522
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 15, 2009
Last Update Posted : February 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 14, 2009
First Posted Date  ICMJE September 15, 2009
Last Update Posted Date February 7, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2009)
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score [ Time Frame: 12 weeks ]
  • Vital Signs (Blood pressure, heart rate) [ Time Frame: 15 weeks ]
  • ECG [ Time Frame: 15 weeks ]
  • Safety laboratory assessments [ Time Frame: 15 weeks ]
  • Adverse events [ Time Frame: 15 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • Positive and Negative Syndrome Scale Negative Subscale [ Time Frame: 12 weeks ]
  • Vital signs [ Time Frame: 15 weeks ]
  • ECG [ Time Frame: 15 weeks ]
  • Safety laboratory assessments [ Time Frame: 15 weeks ]
Change History Complete list of historical versions of study NCT00977522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2009)
  • Change from baseline in Quality of Life Scale (QLS) [ Time Frame: 12 weeks ]
  • Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores [ Time Frame: 12 weeks ]
  • Change from baseline in PANSS Total [ Time Frame: 12 weeks ]
  • Change from baseline in PANSS Positive Subscale [ Time Frame: 12 weeks ]
  • Change from baseline in PANSS General Subscale [ Time Frame: 12 weeks ]
  • Change from baseline in Clinical Global Impression Severity (CGI-S) [ Time Frame: 12 weeks ]
  • Clinical Global Impression Improvement (CGI-I) Total Score [ Time Frame: 12 weeks ]
  • Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified [ Time Frame: 12 weeks ]
  • Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale [ Time Frame: 12 weeks ]
  • Change from baseline in Global Assessment of Functioning [ Time Frame: 12 weeks ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 15 weeks ]
  • Pharmacokinetic assays [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • Quality of Life Scale [ Time Frame: 12 weeks ]
  • MATRICS Consensus Cognitive Battery [ Time Frame: 12 weeks ]
  • Positive and Negative Syndrome Scale Total [ Time Frame: 12 weeks ]
  • Positive and Negative Syndrome Scale Positive Subscale [ Time Frame: 12 weeks ]
  • Positive and Negative Syndrome Scale General Subscale [ Time Frame: 12 weeks ]
  • Clinical Global Impression Severity [ Time Frame: 12 weeks ]
  • Clinical Global Impression Improvement [ Time Frame: 12 weeks ]
  • Abbreviated Extrapyramidal Symptom Rating Scale [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia
Official Title  ICMJE A Randomized Phase 2, Double-Blind, Placebo-Controlled, Multi-Center Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia Treated With A Stable Dose Of A Second Generation Antipsychotic
Brief Summary This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.
Detailed Description The study was terminated on August 25, 2010 because the study's scientific validity could no longer be supported. The decision to terminate the trial was not based on any safety concerns.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: PF-03463275
    30 mg Controlled Release tablet BID for 12 weeks
  • Drug: Placebo
    Placebo tablet BID
Study Arms  ICMJE
  • Experimental: PF-03463275
    Intervention: Drug: PF-03463275
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 5, 2010)
207
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2009)
200
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype in the residual phase.
  • Subjects must be in ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone, or aripiprazole. Subjects must be on a stable medication treatment regimen for at least 2 months.
  • Evidence of stable symptomatology at least 3 months.

Exclusion Criteria:

  • Female subjects who are pregnant or breastfeeding.
  • Subjects with evidence or history of a clinically significant medical condition which would increase risk or which could interfere with the interpretation of trial results.
  • Subjects who have DSM IV defined psychoactive substance dependence (including alcohol and excluding nicotine and caffeine dependence) within 12 months of screening or substance abuse within 3 months prior to screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00977522
Other Study ID Numbers  ICMJE A9131005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP