Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of California, Los Angeles |
---|---|
Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00221481 |
This study will evaluate how effective mood stabilizers are in the treatment of bipolar disorder with comorbid alcoholism
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: divalproex or olanzapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | An Evaluation of Divalproex vs. Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder |
Estimated Study Completion Date: | March 2006 |
Bipolar affective disorder is a medical illness with substantial morbidity and mortality. Further fueling the severity of this illness is the substantial co-occurrence with substance abuse that together poses an enormous public health problem.
This study will evaluate the efficacy of divaproex sodium (DVPX) vs. olanzapine (ZYP) vs. for alcohol relapse prevention and secondary mood stabilization. Bipolar patients who are actively drinking will be randomized to either Depakote ER ® (flexible dose schedule up to 2500 mg) or Zyprexa® (flexible dose schedule up to 20 mg).
Adjunctive benzodiazepine will be utilized for the treatment of alcohol withdrawal and as an adjunct anxiolytic during the early titration of DVPX and ZYP. Patients who, after 2 weeks, have stabilized will continue in the prophylaxis study which will last up to 46 weeks. Flexible dose scheduling and adjunctive antidepressant treatment as clinically indicated will be done to maximize tolerability, treatment compliance, and mood stability.
The primary outcome measure will be alcohol abuse relapse which will be defined, a priori, as 5 drinks in a 24 hour period. Patients who have a relapse as such defined will be terminated from the study. Secondary alcohol outcome measures (i.e. number of drinking days, % drinking days per month, standard drinks per drinking occasion, craving) will be assessed through the time-line follow-back method. Secondary outcome measures of mood stabilization (major mood relapse and adjunctive medication) will be assessed by prospective life charting.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA Neuropsychiatric Institute | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Mark A Frye, MD | University of California, Los Angeles |
Study ID Numbers: | IRB 00-12-071-11A |
Study First Received: | September 13, 2005 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00221481 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bipolar Alcohol |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Psychotropic Drugs Olanzapine Antiemetics Central Nervous System Depressants Disorders of Environmental Origin Antipsychotic Agents Antimanic Agents Serotonin Uptake Inhibitors Valproic Acid |
Serotonin Affective Disorders, Psychotic Mental Disorders Alcoholism Mood Disorders Substance-Related Disorders Psychotic Disorders Alcohol-Related Disorders Peripheral Nervous System Agents Anticonvulsants Ethanol |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Disorders of Environmental Origin Valproic Acid Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Substance-Related Disorders Alcohol-Related Disorders |
Disease Tranquilizing Agents Bipolar Disorder Gastrointestinal Agents Central Nervous System Depressants Enzyme Inhibitors Antipsychotic Agents Antimanic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Alcoholism Mood Disorders GABA Agents |