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Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness Clinical research trials and Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness. Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness
Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness
For Condition: Bipolar Disorder
Status: Recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Key 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 Key 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
Total Enrollment:
Location and Contact Information:
University Hospital of Cleveland *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Duare Valenzuela 216-844-5390
R. Ranjan, MD & Associates, Inc. *Recruiting*
Lyndhurst, Ohio, 44124
United States
Recruiting John Lacombe 216-381-9455
IPS Research *Recruiting*
Oklahoma City, Oklahoma, 73103
United States
Recruiting Jason Oller 405-235-8188
Segal Institute for Clinical Research *Recruiting*
Miami, Florida, 33161
United States
Recruiting Sohail Punjwani 305-891-0050
Rush Presbyterian - St. Luke's *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Selika Gutierrez 312-980-6356
University of Louisville Outpatient Psychiatry *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting Mimi Webster 502-852-1943
Synergy Clinical Research *Recruiting*
Chula Vista, California, 91910
United States
Recruiting Woody Woodaman 619-426-7272
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting Kim Laubmeier 601-984-5831
Lake Mead Hospital *Recruiting*
Las Vegas, Nevada, 89030
United States
Recruiting Debbie Martz 702-657-5648
Segal Institute for Clinical Research *Recruiting*
Miami, Florida, 33161
United States
Recruiting Scott Segal 305-891-0050
NYU School of Medicine *Recruiting*
New York City, New York, 10016
United States
Recruiting Nancy Richardson 212-562-7310
Behavioral and Medical Research, LLC *Recruiting*
Anaheim, California, 92805
United States
Recruiting Holly Name not released 714-774-4800
Zablocki VAMC *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Kristen Phillips 414-384-2000
Creighton University Department of Psychiatry *Recruiting*
Omaha, Nebraska, 68131
United States
Recruiting Sara Wolf 402-345-8828
UTMB Dept. of Psychiatry *Recruiting*
Galveston, Texas, 77555-0197
United States
Recruiting Blanca Moya 409-747-8350
Clinical Trial Management *Recruiting*
Ft. Myers, Florida, 33907
United States
Recruiting Cynthia Johnstone 941-637-6572
Additional Information:
Study ID Numbers: M02-551;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071253
Other Bipolar Disorder Studies:
1. Magnetic Resonance Imaging (MRI) of Neuropsychiatric Patients and Healthy Volunteers
2. Effects of Sex Hormones on Circadian Rhythm in Men and Women
3. Bipolar Disorder Study
4. Clinical Trial of Pramipexole in Bipolar Depression
5. Maintenance Therapies in Bipolar Disorders
Related Studies:
Other Bipolar Disorder Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects during the Maintenance Phase of Bipolar Illness
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