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NCT00567203 Clinical Trial

A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00567203
Other study ID # A9131004
Secondary ID
Status Completed
Phase Phase 1
First received December 3, 2007
Last updated October 1, 2008
Start date November 2007
Est. completion date May 2008

Study information
Verified date October 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PF-3463275
PF-3463275 10mg
• PF-3463275
PF-3463275 25mg
• Placebo
Placebo

Locations
Country Name City State
United States Pfizer Investigational Site Glendale California
United States Pfizer Investigational Site Willingboro New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in the CNS Vital Signs Cognition Battery composite score 6 days No
Primary Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's. 38 days Yes
Primary Pharmacokinetics of PF-3463275 6 days No
Secondary Positive and Negative Syndrome Scale (PANSS) 6 days No
Secondary Change from baseline in the CNS Vital Signs Cognition Battery domain scores 6 days No
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