Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
A Randomized, Double-Blind Study of Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
1 other identifier
interventional
180
1 country
15
Brief Summary
The purpose of this study is to assess the efficacy and safety of continued combination therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy in stable subjects during the maintenance phase of bipolar illness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
15 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
October 16, 2003
CompletedFirst Posted
Study publicly available on registry
October 20, 2003
CompletedAugust 4, 2006
August 1, 2006
October 16, 2003
August 2, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
CGI-s
CGI-i
MRS
DSS
SADS-C
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV-TR primary diagnosis of Bipolar I Disorder as confirmed by the SCID
- 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
You may not qualify if:
- History of schizophrenia or schizoaffective disorder
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (15)
Behavioral and Medical Research, LLC
Anaheim, California, 92805, United States
Synergy Clinical Research
Chula Vista, California, 91910, United States
Clinical Trial Management
Fort Meyers, Florida, 33907, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Rush Presbyterian - St. Luke's
Chicago, Illinois, 60612, United States
University of Louisville Outpatient Psychiatry
Louisville, Kentucky, 40202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Creighton University Department of Psychiatry
Omaha, Nebraska, 68131, United States
Lake Mead Hospital
North Las Vegas, Nevada, 89030, United States
NYU School of Medicine
New York, New York, 10016, United States
University Hospital of Cleveland
Cleveland, Ohio, 44106, United States
R. Ranjan, MD & Associates, Inc.
Lyndhurst, Ohio, 44124, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
UTMB Dept. of Psychiatry
Galveston, Texas, 77555-0197, United States
Zablocki VAMC
Milwaukee, Wisconsin, 53295, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Medical Information
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2003
First Posted
October 20, 2003
Study Start
July 1, 2003
Last Updated
August 4, 2006
Record last verified: 2006-08