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

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Divalproex Sodium (Delayed-Release Tablets) Drug: Divalproex Sodium (Extended-Release Tablets) Drug: Olanzapine	Phase IV

MedlinePlus related topics:

Bipolar Disorder

Drug Information available for:

Divalproex sodium Valproate Sodium Valproic acid Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Abbott:

Primary Outcome Measures:

CGI-s
CGI-i
MRS
DSS
SADS-C

Estimated Enrollment:	180
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071253

Locations


United States, California
	Synergy Clinical Research
	Chula Vista, California, United States, 91910
	Behavioral and Medical Research, LLC
	Anaheim, California, United States, 92805

United States, Florida
	Segal Institute for Clinical Research
	North Miami, Florida, United States, 33161
	Segal Institute for Clinical Research
	North Miami, Florida, United States, 33161
	Clinical Trial Management
	Fort Meyers, Florida, United States, 33907

United States, Illinois
	Rush Presbyterian - St. Luke's
	Chicago, Illinois, United States, 60612

United States, Kentucky
	University of Louisville Outpatient Psychiatry
	Louisville, Kentucky, United States, 40202

United States, Mississippi
	University of Mississippi Medical Center
	Jackson, Mississippi, United States, 39216

United States, Nebraska
	Creighton University Department of Psychiatry
	Omaha, Nebraska, United States, 68131

United States, Nevada
	Lake Mead Hospital
	North Las Vegas, Nevada, United States, 89030

United States, New York
	NYU School of Medicine
	New York City, New York, United States, 10016

United States, Ohio
	R. Ranjan, MD & Associates, Inc.
	Lyndhurst, Ohio, United States, 44124
	University Hospital of Cleveland
	Cleveland, Ohio, United States, 44106

United States, Oklahoma
	IPS Research
	Oklahoma City, Oklahoma, United States, 73103

United States, Texas
	UTMB Dept. of Psychiatry
	Galveston, Texas, United States, 77555-0197

United States, Wisconsin
	Zablocki VAMC
	Milwaukee, Wisconsin, United States, 53295

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Global Medical Information	Abbott

More Information

Study ID Numbers:	M02-551
First Received:	October 16, 2003
Last Updated:	August 2, 2006
ClinicalTrials.gov Identifier:	NCT00071253
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Bipolar Disorder - Mania

Study placed in the following topic categories:

Affective Disorders, Psychotic

Mental Disorders

Bipolar Disorder

Olanzapine

Mood Disorders

Psychotic Disorders

Valproic Acid

Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Psychotropic Drugs

Antiemetics

Central Nervous System Depressants

Enzyme Inhibitors

Antipsychotic Agents

Antimanic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Autonomic Agents

Therapeutic Uses

GABA Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00071253