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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00977522
First received: September 14, 2009
Last updated: February 2, 2012
Last verified: February 2012

September 14, 2009
February 2, 2012
November 2009
September 2010   (final data collection date for primary outcome measure)
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Vital Signs (Blood pressure, heart rate) [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • Safety laboratory assessments [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • Positive and Negative Syndrome Scale Negative Subscale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • ECG [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • Safety laboratory assessments [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00977522 on ClinicalTrials.gov Archive Site
  • Change from baseline in Quality of Life Scale (QLS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in PANSS Total [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in PANSS Positive Subscale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in PANSS General Subscale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Global Impression Severity (CGI-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement (CGI-I) Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in Global Assessment of Functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic assays [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • MATRICS Consensus Cognitive Battery [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale Total [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale Positive Subscale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale General Subscale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Abbreviated Extrapyramidal Symptom Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: PF-03463275
    30 mg Controlled Release tablet BID for 12 weeks
  • Drug: Placebo
    Placebo tablet BID
  • Experimental: PF-03463275
    Intervention: Drug: PF-03463275
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
207
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00977522
A9131005
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

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