Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia
A Study of the Safety and Efficacy of Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia
1 other identifier
interventional
400
1 country
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 17, 2003
CompletedFirst Posted
Study publicly available on registry
November 18, 2003
CompletedAugust 4, 2006
August 1, 2006
November 17, 2003
August 2, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
The psychiatric rating scale battery will include the PANSS, the CGI Scale, and the CDSS. The NOSIE, Overall Treatment Evaluation, Burden Questionnaire, and Quality of Life Scale.
Secondary Outcomes (1)
The movement rating scale battery will include the Simpson-Angus Scale (SAS), the Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (35)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tuscaloosa, Alabama, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Cerritos, California, United States
Unknown Facility
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
Unknown Facility
Falls Church, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Medical Information 800-633-9110
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2003
First Posted
November 18, 2003
Study Start
July 1, 2003
Last Updated
August 4, 2006
Record last verified: 2006-08