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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

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ClinicalTrials.gov Identifier: NCT00071253
Recruitment Status : Terminated
First Posted : October 20, 2003
Last Update Posted : August 4, 2006
Sponsor:
Information provided by:
Abbott

October 16, 2003
October 20, 2003
August 4, 2006
July 2003
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  • CGI-s
  • CGI-i
  • MRS
  • DSS
  • SADS-C
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Complete list of historical versions of study NCT00071253 on ClinicalTrials.gov Archive Site
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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
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Divalproex Sodium (Delayed-Release Tablets)
  • Drug: Divalproex Sodium (Extended-Release Tablets)
  • Drug: Olanzapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
180
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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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00071253
M02-551
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Abbott
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Study Director: Global Medical Information Abbott
Abbott
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP