A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00567203
First received: December 3, 2007
Last updated: October 1, 2008
Last verified: October 2008
  Purpose

The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: PF-3463275
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in the CNS Vital Signs Cognition Battery composite score [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's. [ Time Frame: 38 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of PF-3463275 [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Change from baseline in the CNS Vital Signs Cognition Battery domain scores [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PF-3463275
PF-3463275 10mg
Experimental: 2 Drug: PF-3463275
PF-3463275 25mg
Placebo Comparator: 3 Drug: Placebo
Placebo

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of schizophrenia
  • In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
  • Stable symptoms of schizophrenia for at least 3 months.

Exclusion Criteria:

  • Subjects with a psychiatric disorder other than schizophrenia
  • Substance dependence or abuse
  • Women who have child bearing potential.
  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: NCT00567203

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
United States, New Jersey
Pfizer Investigational Site
Willingboro, New Jersey, United States, 08046
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00567203     History of Changes
Other Study ID Numbers: A9131004
Study First Received: December 3, 2007
Last Updated: October 1, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014