Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
NCT ID: NCT00071253
Last Updated: 2006-08-04
Study Results
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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TERMINATED
PHASE4
180 participants
INTERVENTIONAL
2003-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Divalproex Sodium (Delayed-Release Tablets)
Divalproex Sodium (Extended-Release Tablets)
Olanzapine
Eligibility Criteria
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Inclusion Criteria
* Outpatient receiving treatment with a combination of Depakote plus olanzapine for their bipolar illness and considered clinically stable (e.g., no more than minimal symptoms, no psychiatric hospitalizations, no increase in intensity of clinical interventions) for the preceding 4 months
* Identified at Screening a most bothersome side effect listed in the UKU which makes switching to monotherapy desirable
* MRS total score \< 12 on two consecutive ratings, separated by at least 5 days (Screening and Day 1)
* DSS score \< 13 on two consecutive ratings, separated by at least five days (Screening and Day 1)
* CGI-S score \< 3 on two consecutive ratings, separated by at least five days (Screening and Day 1)
* Serum valproate level \> 45 mcg/mL, and a maximum allowable dose of Depakote of 3000 mg/day at Screening
* Olanzapine dose between 5 and 20 mg/day at Screening
Exclusion Criteria
* Axis I (e.g., anxiety disorder) or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
* Has taken antipsychotics, mood stabilizers, or anticonvulsants (unless specifically for seizure control) other than Depakote or olanzapine in the four months prior to randomization. Other psychotropics (e.g., antidepressants, anxiolytics) with the exception of stimulants, that have been used routinely to maintain stability in the preceding four months may be continued, but not increased or decreased
* Has first manic episode after age 60
* Has ever taken clozapine
* Has received depot neuroleptic medication within six months of randomization
* Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
* History of active alcohol or substance abuse/dependence within 90 days prior to Screening
* Known history of non-response to either Depakote or olanzapine monotherapy for the treatment of bipolar disorder
18 Years
65 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Global Medical Information
Role: STUDY_DIRECTOR
Abbott
Locations
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Behavioral and Medical Research, LLC
Anaheim, California, United States
Synergy Clinical Research
Chula Vista, California, United States
Clinical Trial Management
Fort Meyers, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Rush Presbyterian - St. Luke's
Chicago, Illinois, United States
University of Louisville Outpatient Psychiatry
Louisville, Kentucky, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Creighton University Department of Psychiatry
Omaha, Nebraska, United States
Lake Mead Hospital
North Las Vegas, Nevada, United States
NYU School of Medicine
New York, New York, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
R. Ranjan, MD & Associates, Inc.
Lyndhurst, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
UTMB Dept. of Psychiatry
Galveston, Texas, United States
Zablocki VAMC
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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M02-551
Identifier Type: -
Identifier Source: org_study_id