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	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Divalproex Sodium Delayed-Release Tablets  Drug: Divalproex Sodium Extended-Release Tablets  Drug: Olanzapine	Phase IV

Further Study Details: 

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Key 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

Key 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

California
      Synergy Clinical Research, Chula Vista,  California,  91910,  United States
      Behavioral and Medical Research, LLC, Anaheim,  California,  92805,  United States
Florida
      Segal Institute for Clinical Research, North Miami,  Florida,  33161,  United States
      Segal Institute for Clinical Research, North Miami,  Florida,  33161,  United States
      Clinical Trial Management, Fort Meyers,  Florida,  33907,  United States
Illinois
      Rush Presbyterian - St. Luke's, Chicago,  Illinois,  60612,  United States
Kentucky
      University of Louisville Outpatient Psychiatry, Louisville,  Kentucky,  40202,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216,  United States
Nebraska
      Creighton University Department of Psychiatry, Omaha,  Nebraska,  68131,  United States
Nevada
      Lake Mead Hospital, North Las Vegas,  Nevada,  89030,  United States
New York
      NYU School of Medicine, New York City,  New York,  10016,  United States
Ohio
      R. Ranjan, MD & Associates, Inc., Lyndhurst,  Ohio,  44124,  United States
      University Hospital of Cleveland, Cleveland,  Ohio,  44106,  United States
Oklahoma
      IPS Research, Oklahoma City,  Oklahoma,  73103,  United States
Texas
      UTMB Dept. of Psychiatry, Galveston,  Texas,  77555-0197,  United States
Wisconsin
      Zablocki VAMC, Milwaukee,  Wisconsin,  53295,  United States

Study ID Numbers:  M02-551
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  October 16, 2003
ClinicalTrials.gov Identifier:  NCT00071253
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08