Clinical trial NCT00071253: Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder - Mania
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-10-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: CGI-s
measure: CGI-i
measure: MRS
measure: DSS
measure: SADS-C
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Behavioral and Medical Research, LLC
state: California
city: Chula Vista
country: United States
facility: Synergy Clinical Research
state: California
city: Fort Meyers
country: United States
facility: Clinical Trial Management
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Chicago
country: United States
facility: Rush Presbyterian - St. Luke's
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Outpatient Psychiatry
state: Kentucky
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Omaha
country: United States
facility: Creighton University Department of Psychiatry
state: Nebraska
city: North Las Vegas
country: United States
facility: Lake Mead Hospital
state: Nevada
city: New York City
country: United States
facility: NYU School of Medicine
state: New York
city: Cleveland
country: United States
facility: University Hospital of Cleveland
state: Ohio
city: Lyndhurst
country: United States
facility: R. Ranjan, MD & Associates, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Galveston
country: United States
facility: UTMB Dept. of Psychiatry
state: Texas
city: Milwaukee
country: United States
facility: Zablocki VAMC
state: Wisconsin
Study officials:
affiliation: Abbott
name: Global Medical Information
role: STUDY_DIRECTOR
References: