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| Sponsor: | University of Cincinnati |
|---|---|
| Collaborator: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Information provided by: | University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00550394 |
Purpose
The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study the effects (both good and bad) of combining quetiapine and topiramate for reducing use of alcohol.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Alcohol Abuse |
Drug: quetiapine + placebo Drug: Quetiapine + Topiramate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Quetiapine Plus Topiramate or Placebo for Bipolar Mania and Alcohol Use in Adolescents & Young Adults |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Quetiapine + Placebo
|
Drug: quetiapine + placebo
Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1 Dosing Schedule and Titration of Topiramate: All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner. Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4. Other Name: Placebo
|
|
Experimental: 2
Quetiapine + Topiramate
|
Drug: Quetiapine + Topiramate
Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1 Dosing Schedule and Titration of Topiramate: All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner. Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4. Other Name: Topiramate
|
Specific Aim 1: To collect preliminary data regarding the efficacy and tolerability of topiramate for the treatment of alcohol use disorders (alcohol abuse and dependence) in adolescents with bipolar disorder.
Hypothesis 1: We hypothesize that topiramate in combination with quetiapine will lead to greater reduction in alcohol consumption (number of drinks per day, number of drinks per drinking day, and number of heavy drinking days) and greater abstinence (percentage of days abstinent) compared with quetiapine alone.
Specific Aim 2: To obtain preliminary data regarding the efficacy of topiramate for reducing manic symptoms in adolescents with co-occurring alcohol use and bipolar disorders.
Hypothesis 2: We hypothesize that the topiramate in combination with quetiapine will produce greater reduction in Young Mania Rating Scale (YMRS) scores than quetiapine alone.
Eligibility| Ages Eligible for Study: | 12 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Drinking >8 drinks in 30 days within the previous 6 months while meeting DSM-IV criteria for alcohol abuse or dependence.
One standard drink is defined as 0.35 liters of beer, 0.15 liters of wine, or 0.04 liters of 80-proof liquor;
Exclusion Criteria:
Contacts and Locations| Contact: Jennifer Beavers | 513-558-6195 | jennifer.beavers@uc.edu |
| United States, Ohio | |
| University of Cincinnati Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45227 | |
| Contact: Jennifer Beavers 513-558-6195 jennifer.beavers@uc.edu | |
| Principal Investigator: Melissa DelBello, MD | |
| Principal Investigator: | Melissa P DelBello, MD | University of Cincinnati |
More Information
| Responsible Party: | Melissa P. DelBello, MD, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00550394 History of Changes |
| Other Study ID Numbers: | NIAAA |
| Study First Received: | October 25, 2007 |
| Last Updated: | February 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Adolescents |
|
Alcohol Drinking Bipolar Disorder Alcoholism Drinking Behavior Affective Disorders, Psychotic Mood Disorders Mental Disorders Alcohol-Related Disorders Substance-Related Disorders Topiramate Quetiapine Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |