Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202514
Status:
COMPLETED
Last Update Posted:
2009-10-08
First Post:
2005-09-12
Brief Title:
Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood andor Anxiety Symptoms
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood andor Anxiety Symptoms
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium Depakote ER for the treatment of people with alcohol dependence who have mood andor anxiety symptoms This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol
Detailed Description:
Alcohol dependence afflicts 14 million individuals in the US The alcohol related costs to society are enormous and alcohol dependence is a significant public health problem Although pharmacotherapy for the treatment of alcohol dependence and relapse prevention has expanded the identification of evidence based treatment strategies is of critical importance Anticonvulsants including the divalproex sodium DVP formulation of valproate have established effectiveness for mood disorders and therapeutic response of mood and anxiety symptoms to DVP has been demonstrated in a number of psychiatric conditions While DVP has been demonstrated as a treatment option for the acute alcohol withdrawal syndrome a clear treatment effect has not been found in studies examining DVP for ongoing relapse prevention in alcohol dependence These latter studies had limited power and excluded subjects with co-morbid mood and anxiety disorders individuals who may by extension of the former studies show the greatest response to treatment with DVP Despite the exclusion of subjects with mood and anxiety disorders alcohol dependent individuals treated with DVP compared to placebo showed greater improvement in irritability and a trend toward greater decreases on measures of impulsivity and aggression A strategy integrating the above findings would target treatment with DVP more specifically to alcohol dependent individuals with mood and anxiety disturbances
This randomized double-blind clinical trial will examine the effectiveness of extended release DVP Depakote-ER in the treatment of co-morbid mood and anxiety disturbance in alcohol dependent subjects The primary hypothesis is that subjects treated with Depakote-ER will have significantly lower scores on the Symptom Checklist SCL-90-R than will placebo treated subjects over the course of the study Secondary hypotheses include 1 Compared to placebo treated subjects subjects treated with Depakote-ER will demonstrate significantly lower scores on additional measures of depression anxiety and irritability 2 will have fewer alcohol use days and fewer drinks per drinking day and 3 will evidence better retention in alcohol dependence treatment
Eligible subjects will complete baseline assessments and a 7-day run on Depakote-ER prior to randomization After the 7-day baseline period and run in with Depakote-ER subjects will be randomized and then transition to either 12 weeks of Depakote-ER or placebo to begin upon completion of the 7-day run-in baseline period Valproic acid level obtained at the end of the baseline period will be used to adjust the dose of Depakote-ER or matched placebo as needed to target a valproic level of 70-120 ugml Dose increase if needed will occur with the study medication dispensed at the next follow up visit scheduled for the end of the 1st week of active study medication or placebo Subjects with valproic acid levels 120 ugml at the end of the baseline period will be contacted as soon as possible and instructed to decrease their dose of Depakote-ER or matched placebo accordingly Subjects randomized to the placebo condition will receive a placebo matched in number and appearance to the dosage of Depakote-ER prescribed during the 7-day baseline period If needed the number of placebo pills will be adjusted to match the change in the Depakote-ER dosage determined necessary based on the valproic acid level obtained at the end of the 7-day baseline period
Duration of Subject Participation Subjects will receive either divalproex sodium extended release Depakote-ER or matched placebo for 12 weeks Subjects will continue to receive other treatment as usual within the Addiction Treatment Center in accordance with their ongoing clinical program treatment plan The standard expectation within the context of treatment as usual is for at least 6 months of treatment involvement A limited number of psychotropic medications will be allowed during the study A benzodiazepine usually chlordiazepoxide or lorazepam in accordance with standard practice and generally given in an as needed symptom triggered manner can be prescribed during the acute detoxification period first 7 days Hydroxyzine can be prescribed PRN for anxiety and zolpidem PRN not to exceed 5 nights per week for insomnia throughout the course of the study
This randomized double-blind clinical trial will examine the effectiveness of extended release DVP Depakote-ER in the treatment of co-morbid mood and anxiety disturbance in alcohol dependent subjects The primary hypothesis is that subjects treated with Depakote-ER will have significantly lower scores on the Symptom Checklist SCL-90-R than will placebo treated subjects over the course of the study Secondary hypotheses include 1 Compared to placebo treated subjects subjects treated with Depakote-ER will demonstrate significantly lower scores on additional measures of depression anxiety and irritability 2 will have fewer alcohol use days and fewer drinks per drinking day and 3 will evidence better retention in alcohol dependence treatment
Eligible subjects will complete baseline assessments and a 7-day run on Depakote-ER prior to randomization After the 7-day baseline period and run in with Depakote-ER subjects will be randomized and then transition to either 12 weeks of Depakote-ER or placebo to begin upon completion of the 7-day run-in baseline period Valproic acid level obtained at the end of the baseline period will be used to adjust the dose of Depakote-ER or matched placebo as needed to target a valproic level of 70-120 ugml Dose increase if needed will occur with the study medication dispensed at the next follow up visit scheduled for the end of the 1st week of active study medication or placebo Subjects with valproic acid levels 120 ugml at the end of the baseline period will be contacted as soon as possible and instructed to decrease their dose of Depakote-ER or matched placebo accordingly Subjects randomized to the placebo condition will receive a placebo matched in number and appearance to the dosage of Depakote-ER prescribed during the 7-day baseline period If needed the number of placebo pills will be adjusted to match the change in the Depakote-ER dosage determined necessary based on the valproic acid level obtained at the end of the 7-day baseline period
Duration of Subject Participation Subjects will receive either divalproex sodium extended release Depakote-ER or matched placebo for 12 weeks Subjects will continue to receive other treatment as usual within the Addiction Treatment Center in accordance with their ongoing clinical program treatment plan The standard expectation within the context of treatment as usual is for at least 6 months of treatment involvement A limited number of psychotropic medications will be allowed during the study A benzodiazepine usually chlordiazepoxide or lorazepam in accordance with standard practice and generally given in an as needed symptom triggered manner can be prescribed during the acute detoxification period first 7 days Hydroxyzine can be prescribed PRN for anxiety and zolpidem PRN not to exceed 5 nights per week for insomnia throughout the course of the study
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