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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Divalproex sodium Valproic acid Olanzapine Valproate Sodium

U.S. FDA Resources

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
Behavioral and Medical Research, LLC
Anaheim, California, United States, 92805
Synergy Clinical Research
Chula Vista, California, United States, 91910
United States, Florida
Clinical Trial Management
Fort Meyers, Florida, United States, 33907
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
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
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
R. Ranjan, MD & Associates, Inc.
Lyndhurst, Ohio, United States, 44124
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

No publications provided

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

Keywords provided by Abbott:

Bipolar Disorder - Mania

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Olanzapine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents

Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 12, 2012