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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 | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

NCT00071253•Abbott

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (15)

Behavioral and Medical Research, LLC

Anaheim, California, United States

Synergy Clinical Research

Chula Vista, California, United States

Clinical Trial Management

Fort Meyers, Florida, United States

Segal Institute for Clinical Research

North Miami, Florida, United States

Rush Presbyterian - St. Luke's

Chicago, Illinois, United States

University of Louisville Outpatient Psychiatry

Louisville, Kentucky, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Creighton University Department of Psychiatry

Omaha, Nebraska, United States

Lake Mead Hospital

North Las Vegas, Nevada, United States

NYU School of Medicine

New York, New York, United States

Key Dates

Start Date

July 1, 2003

Last Updated

August 4, 2006

Enrollment

180

Estimated participants

Conditions

Bipolar Disorder

Interventions

Divalproex Sodium (Delayed-Release Tablets)

DRUG

Divalproex Sodium (Extended-Release Tablets)

DRUG

Olanzapine

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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