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

  Show 37 Study Locations
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 July 28, 2014