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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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NCT00977522

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Cerritos, California, 90703 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00977522
Pfizer
Terminated
A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia

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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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00977522
A9131005
No
Not Provided
Not Provided
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

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