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

August 2, 2006 updated by: Abbott

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
CGI-s
CGI-i
MRS
DSS
SADS-C

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Global Medical Information, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Registration Dates

First Submitted

October 16, 2003

First Submitted That Met QC Criteria

October 17, 2003

First Posted (Estimate)

October 20, 2003

Study Record Updates

Last Update Posted (Estimate)

August 4, 2006

Last Update Submitted That Met QC Criteria

August 2, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on Olanzapine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe