Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Divalproex Sodium (Delayed-Release Tablets) (Drug); Divalproex Sodium (Extended-Release Tablets) (Drug); Olanzapine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Global Medical Information, Study Director, Affiliation: Abbott
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: CGI-sCGI-i MRS DSS SADS-C
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Synergy Clinical Research, Chula Vista, California 91910, United States
Behavioral and Medical Research, LLC, Anaheim, California 92805, United States
Segal Institute for Clinical Research, North Miami, Florida 33161, United States
Segal Institute for Clinical Research, North Miami, Florida 33161, United States
Clinical Trial Management, Fort Meyers, Florida 33907, United States
Rush Presbyterian - St. Luke's, Chicago, Illinois 60612, United States
University of Louisville Outpatient Psychiatry, Louisville, Kentucky 40202, United States
University of Mississippi Medical Center, Jackson, Mississippi 39216, United States
Creighton University Department of Psychiatry, Omaha, Nebraska 68131, United States
Lake Mead Hospital, North Las Vegas, Nevada 89030, United States
NYU School of Medicine, New York City, New York 10016, United States
R. Ranjan, MD & Associates, Inc., Lyndhurst, Ohio 44124, United States
University Hospital of Cleveland, Cleveland, Ohio 44106, United States
IPS Research, Oklahoma City, Oklahoma 73103, United States
UTMB Dept. of Psychiatry, Galveston, Texas 77555-0197, United States
Zablocki VAMC, Milwaukee, Wisconsin 53295, United States
Additional Information
Starting date: July 2003
Last updated: August 2, 2006
|
