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Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00071253
Recruitment Status : Terminated
First Posted : October 20, 2003
Last Update Posted : August 4, 2006
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Divalproex Sodium (Delayed-Release Tablets) Drug: Divalproex Sodium (Extended-Release Tablets) Drug: Olanzapine Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2003

Primary Outcome Measures :
  1. CGI-s
  2. CGI-i
  3. MRS
  4. DSS
  5. SADS-C

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00071253

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United States, California
Behavioral and Medical Research, LLC
Anaheim, California, United States, 92805
Synergy Clinical Research
Chula Vista, California, United States, 91910
United States, Florida
Clinical Trial Management
Fort Meyers, Florida, United States, 33907
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
United States, Illinois
Rush Presbyterian - St. Luke's
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Louisville Outpatient Psychiatry
Louisville, Kentucky, United States, 40202
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Nebraska
Creighton University Department of Psychiatry
Omaha, Nebraska, United States, 68131
United States, Nevada
Lake Mead Hospital
North Las Vegas, Nevada, United States, 89030
United States, New York
NYU School of Medicine
New York City, New York, United States, 10016
United States, Ohio
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
R. Ranjan, MD & Associates, Inc.
Lyndhurst, Ohio, United States, 44124
United States, Oklahoma
IPS Research
Oklahoma City, Oklahoma, United States, 73103
United States, Texas
UTMB Dept. of Psychiatry
Galveston, Texas, United States, 77555-0197
United States, Wisconsin
Zablocki VAMC
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
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Study Director: Global Medical Information Abbott
Layout table for additonal information Identifier: NCT00071253    
Other Study ID Numbers: M02-551
First Posted: October 20, 2003    Key Record Dates
Last Update Posted: August 4, 2006
Last Verified: August 2006
Keywords provided by Abbott:
Bipolar Disorder - Mania
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Enzyme Inhibitors
GABA Agents
Antimanic Agents