A Phase 4 interventional study of divalproex or olanzapine in Bipolar Disorder, sponsored by Mayo Clinic. Withdrawn at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-06-01.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
This study will evaluate how effective mood stabilizers are in the treatment of bipolar disorder with comorbid alcoholism
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
Browse Alcoholism studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This study is withdrawn, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic