Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia

NCT ID: NCT00528905

Last Updated: 2008-11-25

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

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia Cognitive Deficits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

AZD3480

Intervention Type DRUG

oral capsule

2

AZD3480 oral

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

oral capsule

3

AZD3480 oral dose

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

oral capsule

Interventions

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AZD3480

oral capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of schizophrenia
* Outpatient at the time of screening and randomization
* Stable housing defined as having a place to live in the community (ie, not in a hospital or nursing home)
* Active cigarette smoking (10 or more cigarettes per day

Exclusion Criteria

* Any significant psychiatric or neurological disease other than schizophrenia, or current diagnosis of major depressive disorder
* Known or suspected drug or alcohol abuse within the 6 months or urine toxicology test positive for illegal or non-prescribed substances
* Impaired vision and/or hearing making cognitive testing difficult
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Larry Rodichok, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Cerritos, California, United States

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Costa Mesa, California, United States

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Escondido, California, United States

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Garden Grove, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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Pasadena, California, United States

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Pico Rivera, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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New Britain, Connecticut, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Coral Gables, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Joliet, Illinois, United States

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Schaumburg, Illinois, United States

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Indianapolis, Indiana, United States

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New Orleans, Louisiana, United States

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Glen Burnie, Maryland, United States

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Haverhill, Massachusetts, United States

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Pittsfield, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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Cherry Hill, New Jersey, United States

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Clementon, New Jersey, United States

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East Orange, New Jersey, United States

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Newark, New Jersey, United States

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Paramus, New Jersey, United States

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Brooklyn, New York, United States

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Cedarhurst, New York, United States

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Elmsford, New York, United States

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Glen Oaks, New York, United States

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Jamaica, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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DuBois, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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DeSoto, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Calgary, Alberta, Canada

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Red Deer, Alberta, Canada

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Penticton, British Columbia, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Sydney, Nova Scotia, Canada

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Burlington, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Mississauga, Ontario, Canada

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Orléans, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Montreal, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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D3690C00011

Identifier Type: -

Identifier Source: org_study_id