A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

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

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
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


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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567203

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
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 and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014