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Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia

NCT ID: NCT00073164

Last Updated: 2006-08-04

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

2003-07-31

Brief Summary

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The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy with olanzapine or risperidone for the treatment 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Divalproex Sodium Extended-Release Tablets

Intervention Type DRUG

Olanzapine

Intervention Type DRUG

Risperidone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acute exacerbation of schizophrenia as defined by: subject recently hospitalized or is in the process of being admitted to a hospital or an acute care inpatient psychiatric treatment facility; and has a PANNS Total score of 70 or greater at the time of screening and at randomization based on a 1-7 point scale; and has a score on any two of the four items from psychosis cluster of the BPRS (extracted from the PANSS) that correspond to the positive symptoms (hallucinatory behavior, unusual thought content, conceptual disorganization and suspiciousness) totaling 8 or greater; and has a total of 6 or greater on one of the following two pairs of items from the BPRS (extracted from the PANSS): hostility and uncooperativeness or excitement and tension.
* Current DSM-IV-TR diagnosis of schizophrenia as confirmed by the SCID
* Positive response to antipsychotics in the previous 2 years

Exclusion Criteria

* Current diagnosis of schizoaffective disorder, drug-induced psychosis, manic episode or major depressive episode.
* At the time of screening, has been hospitalized for more than 14 days for the current episode
* Has ever taken clozapine
* Has had more than 3 psychiatric hospitalizations in the previous 6 months or has had more than 8 weeks of psychiatric hospitalization in the previous 12 months
* Has serious violent, homicidal, suicidal ideation
* Has received depot medications fluphenazine decanoate and/or haloperidol decanoate within 2 or 4 weeks prior to randomization respectively
* Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
* History of alcohol or substance dependence within the past month
* Has taken any valproate product for a psychiatric indication within the previous 30 days
* Has received an investigational drug within the last 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Medical Information 800-633-9110

Role: STUDY_DIRECTOR

Abbott

Locations

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Birmingham, Alabama, United States

Site Status

Tuscaloosa, Alabama, United States

Site Status

Anaheim, California, United States

Site Status

Cerritos, California, United States

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Chula Vista, California, United States

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Garden Grove, California, United States

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Glendale, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Gainsville, Florida, United States

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Melbourne, Florida, United States

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North Miami, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Hoffman Estates, Illinois, United States

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Indianapolis, Indiana, United States

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South Bend, Indiana, United States

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Shreveport, Louisiana, United States

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Rockville, Maryland, United States

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Jackson, Mississippi, United States

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Clementon, New Jersey, United States

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Kenilworth, New Jersey, United States

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Holliswood, New York, United States

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New York, New York, United States

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Butner, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Falls Church, Virginia, United States

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Countries

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United States

Other Identifiers

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M02-547

Identifier Type: -

Identifier Source: org_study_id