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A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

NCT ID: NCT00567203

Last Updated: 2008-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

PF-3463275

Intervention Type DRUG

PF-3463275 10mg

2

Group Type EXPERIMENTAL

PF-3463275

Intervention Type DRUG

PF-3463275 25mg

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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PF-3463275

PF-3463275 10mg

Intervention Type DRUG

PF-3463275

PF-3463275 25mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Glendale, California, United States

Site Status

Pfizer Investigational Site

Willingboro, New Jersey, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9131004&StudyName=A%20Study%20Of%20Adjunctive%20Treatment%20Of%20Cognitive%20Deficits%20In%20Schizophrenia

To obtain contact information for a study center near you, click here.

Other Identifiers

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A9131004

Identifier Type: -

Identifier Source: org_study_id