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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00071253
• Other study ID #: M02-551
• Status: Terminated
• Phase: Phase 4
• First received: October 16, 2003
• Last updated: August 2, 2006
• Start date: July 2003

Study information

• Verified date: August 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Divalproex Sodium (Delayed-Release Tablets)

• Divalproex Sodium (Extended-Release Tablets)

• Olanzapine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGI-s
Primary	CGI-i
Primary	MRS
Primary	DSS
Primary	SADS-C