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
  Purpose

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 Intervention Phase
Schizophrenia
Drug: PF-03463275
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 207
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-03463275 Drug: PF-03463275
30 mg Controlled Release tablet BID for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo tablet BID

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977522

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Cerritos, California, United States, 90703
Pfizer Investigational Site
Chula Vista, California, United States, 91910
Pfizer Investigational Site
Escondido, California, United States, 92025
Pfizer Investigational Site
Garden Grove, California, United States, 92845
Pfizer Investigational Site
Glendale, California, United States, 91436
Pfizer Investigational Site
Long Beach, California, United States, 90805
Pfizer Investigational Site
Long Beach, California, United States, 90808
Pfizer Investigational Site
National City, California, United States, 91950
Pfizer Investigational Site
Paramount, California, United States, 90723
Pfizer Investigational Site
Torrance, California, United States, 90502
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20016
Pfizer Investigational Site
Washington, District of Columbia, United States, 20036
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
Pfizer Investigational Site
Decatur, Georgia, United States, 30333
United States, Illinois
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
Pfizer Investigational Site
Wichita, Kansas, United States, 67211
United States, Mississippi
Pfizer Investigational Site
Flowood, Mississippi, United States, 39232
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89102
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Pfizer Investigational Site
Runnemede, New Jersey, United States, 08078
Pfizer Investigational Site
Toms River, New Jersey, United States, 08755
Pfizer Investigational Site
Willingboro, New Jersey, United States, 08046
United States, New York
Pfizer Investigational Site
Fresh Meadows, New York, United States, 11366
Pfizer Investigational Site
Holliswood, New York, United States, 11423
Pfizer Investigational Site
Staten Island, New York, United States, 10304
Pfizer Investigational Site
Staten Island, New York, United States, 10305
United States, Oklahoma
Pfizer Investigational Site
Edmond, Oklahoma, United States, 73034
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73116
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19139
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78754
Pfizer Investigational Site
Austin, Texas, United States, 78731
Pfizer Investigational Site
Bellaire, Texas, United States, 77401
Pfizer Investigational Site
Houston, Texas, United States, 77008
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00977522     History of Changes
Other Study ID Numbers: A9131005
Study First Received: September 14, 2009
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
schizophrenia negative symptoms adjunctive

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014