Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221481
Status:
WITHDRAWN
Last Update Posted:
2015-06-01
First Post:
2005-09-13
Brief Title:
An Evaluation of Divalproex vs Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
An Evaluation of Divalproex vs Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder
Status:
WITHDRAWN
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate how effective mood stabilizers are in the treatment of bipolar disorder with comorbid alcoholism
Detailed Description:
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None