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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00977522
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 15, 2009
Last Update Posted : February 7, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: PF-03463275 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: PF-03463275 Drug: PF-03463275
30 mg Controlled Release tablet BID for 12 weeks

Placebo Comparator: Placebo Drug: Placebo
Placebo tablet BID

Primary Outcome Measures :
  1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score [ Time Frame: 12 weeks ]
  2. Vital Signs (Blood pressure, heart rate) [ Time Frame: 15 weeks ]
  3. ECG [ Time Frame: 15 weeks ]
  4. Safety laboratory assessments [ Time Frame: 15 weeks ]
  5. Adverse events [ Time Frame: 15 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Quality of Life Scale (QLS) [ Time Frame: 12 weeks ]
  2. Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores [ Time Frame: 12 weeks ]
  3. Change from baseline in PANSS Total [ Time Frame: 12 weeks ]
  4. Change from baseline in PANSS Positive Subscale [ Time Frame: 12 weeks ]
  5. Change from baseline in PANSS General Subscale [ Time Frame: 12 weeks ]
  6. Change from baseline in Clinical Global Impression Severity (CGI-S) [ Time Frame: 12 weeks ]
  7. Clinical Global Impression Improvement (CGI-I) Total Score [ Time Frame: 12 weeks ]
  8. Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified [ Time Frame: 12 weeks ]
  9. Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale [ Time Frame: 12 weeks ]
  10. Change from baseline in Global Assessment of Functioning [ Time Frame: 12 weeks ]
  11. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 15 weeks ]
  12. Pharmacokinetic assays [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977522

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer Identifier: NCT00977522     History of Changes
Other Study ID Numbers: A9131005
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Pfizer:
schizophrenia negative symptoms adjunctive

Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders