Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00352469|
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : December 8, 2008
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Anxiety Disorders Generalized Anxiety Disorder Post-Traumatic Stress Disorder Panic Disorder Obsessive-Compulsive Disorder||Drug: Seroquel XR||Phase 4|
The objective of this proposal is to study the efficacy of the medication Seroquel SR for the treatment of alcohol dependence and co-morbid anxiety in a prospective double blind placebo-controlled randomized clinical study. Patients, meeting the DSM-IV criteria for Alcohol Dependence and an Anxiety Disorder, will be enrolled and randomized to receive placebo or Seroquel SR. All subjects will be referred to usual treatment program, where they can receive group/self help group therapy.
This is a 12-week prospective, double blind placebo-controlled randomized clinical trial of Seroquel SR in patients who meet the Diagnostic and Statistical Manual of Psychiatric Disorders (DSM-IV) criteria for alcohol dependence and anxiety disorders. Potential candidates will be allowed sufficient time to review the consent document and ask questions about the trial prior to signing the consent document. Consenting adults will be randomized to receive active medication, Seroquel SR or placebo for 12-weeks. The study will enroll 20 patients, 10 will be randomized to receive Seroquel SR, and 10 will receive placebo. All participants will also be referred to usual alcohol treatment, including individual, group and/or self help group therapy (Alcoholics Anonymous).
Subjects will be randomized to receive either Seroquel SR or placebo. Dosing of Seroquel SR will occur on the following schedule: At the baseline visit, Seroquel SR will be started at 50 mg QHS for Day 1 and 2, and dose increase to 150 mg QHS on day 3-4, and increased further to 300 mg QHS from day 5-day 42. After day 5, the Seroquel SR dosage can be increased by up to 100 mg per week to a maximal dose of 400 mg per day. During the treatment period, dose reductions (because of physical illness or adverse event) are allowed for patients taking at least 200 mg per day.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||12 Week Prospective Double Blind Placebo Controlled Randomized Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Placebo Comparator: 2
Subjects will be randomized to receive either Seroquel SR or placebo
Drug: Seroquel XR
Day 1 and 2 Seroquel XR 50 mg; Day 3-4 Seroquel XR 150mg;Day 5-42 Seroquel XR 300-400mg
- Aim 1: To determine whether Seroquel SR reduces alcohol use and prolongs sobriety as measured by the Time Line Follow Back Method and breathalyzer test in individuals with alcohol dependence and co-morbid anxiety. [ Time Frame: Two Years ]
- Aim 2: To determine whether Seroquel SR decreases craving as measured by the Pennsylvania Craving Scale, in individuals with alcohol dependence and co-morbid anxiety. [ Time Frame: Two Years ]
- Aim 3: To determine whether Seroquel SR reduces anxiety symptoms as measured by the Hamilton Rating Scale for Anxiety (HAM-A), in individuals with alcohol dependence and co-morbid anxiety. [ Time Frame: Two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352469
|United States, Nebraska|
|Creighton University Department of Psychiatry|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator:||Pirzada Sattar, MD||Creighton University|