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

Tracking Information

First Received Date ^ICMJE

October 16, 2003

Last Updated Date

August 2, 2006

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

CGI-s
CGI-i
MRS
DSS
SADS-C

Original Primary Outcome Measures ^ICMJE

CGI-s, CGI-i, MRS, DSS, SADS-C

Change History

Complete list of historical versions of study NCT00071253 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: Divalproex Sodium (Delayed-Release Tablets)
Drug: Divalproex Sodium (Extended-Release Tablets)
Drug: Olanzapine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

180

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00071253

Responsible Party

Study ID Numbers ^ICMJE

M02-551

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Medical Information

Abbott

Information Provided By

Abbott

Verification Date

August 2006

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