Quetiapine for Bipolar Disorder and Alcohol Dependence
This study has been completed.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
First received: April 4, 2007
Last updated: April 1, 2016
Last verified: April 2016
The purpose of this study is to find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Quetiapine for Bipolar Disorder and Alcohol Dependence
Primary Outcome Measures:
- The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent of Heavy Drinking Days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Gamma-glutamyltransferase (GGT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
GGT is a liver enzyme measurement (IU/I)
- Aspartate Aminotransferase (AST) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
AST is a liver enzyme measurement (IU/I)
- Alanine Aminotransferase (ALT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
ALT is a liver enzyme measurement (IU/I).
- Hamilton Rating Scale for Depression (HRSD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).
Minimum: 0 Maximum: 50 Lower score associated with better outcome
- Inventory of Depressive Symptomatology-Self Report (IDS-SR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.
Minimum: 0 Maximum: 84 Lower score associated with better outcome
- Young Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).
Minimum: 0 Maximum: 60 Lower score associated with better outcome
- Penn Alcohol Craving Scale (PACS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking
Minimum: 0 Maximum: 30 Lower score associated with better outcome.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2011 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Inactive ingredient matching the active medication in appearance.
Other Name: Sugar-pill
Active Comparator: Quetiapine
This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol dependence and if quetiapine treatment is associated with greater improvement in depressive symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Outpatients with a diagnosis of bipolar I or II disorder, depressed or mixed phase on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) and confirmed by interview with PI or co-I.
- Current diagnosis of alcohol dependence.
- Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to baseline.
- Currently taking a mood stabilizer defined as lithium, divalproex/valproic acid, oxcarbazepine, or lamotrigine at a stable dose for > 14 days.
- Men and women age 18-65 years old.
- English or Spanish speaking.
- Bipolar disorders other than bipolar I or II (e.g., not otherwise specified or cyclothymic disorders) based on the SCID and confirmed through clinical assessment by PI or co-I.
- Baseline Young Mania Rating Scale (YMRS) score > 35 or Hamilton Depression Rating Scale (HRSD) 17 score > 35.
- Current clinically significant psychotic features (hallucinations, delusions, disorganized thought processes).
- Evidence of clinically significant alcohol withdrawal symptoms defined as a Clinical Institute Withdrawal Assessment (CIWA-AR) score of > 8.
- History of hepatic cirrhosis or baseline AST or ALT > 3X upper limit of normal or other clinically significant findings on physical or laboratory examination.
- Mental retardation or other severe cognitive impairment.
- Prison or jail inmates.
- Pregnant or nursing women or women of childbearing age who will not use oral contraceptives, abstinence, or other acceptable methods of birth control during the study.
- Antipsychotic therapy within 14 days prior to randomization.
- Current carbamazepine or benzodiazepine therapy.
- Current treatment with medications shown to reduce alcohol consumption (naltrexone, acamprosate, disulfiram, or topiramate) in large randomized, controlled trials.
- Initiation of antidepressants or mood stabilizers or psychotherapy within past 2 weeks.
- High risk for suicide, defined as any suicide attempts in the past 3 months or current suicidal ideation with plan and intent.
- Intensive outpatient treatment for substance abuse (AA, NA meetings, or other 12-step programs or weekly psychotherapy that started at least 14 days prior to randomization will be allowed).
- Current treatment with ketoconazole, itraconazole, erythromycin, or nefazodone.
- Severe or life-threatening medical condition (e.g., congestive heart failure, terminal cancer) or laboratory or physical examination findings consistent with serious medical illness (e.g., severe edema, atrial fibrillation, dangerously abnormal electrolytes).
- Diabetes mellitus by history or suspected from baseline blood sugar.
- History of cataracts or suspected cataracts on ophthalmic exam
- History of seizure disorder of any etiology; if a subject develops a seizure episode, s/he will be discontinued from the study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457197
|Psychoneuroendocrine Research Program
|Dallas, Texas, United States, 75235 |
University of Texas Southwestern Medical Center
||E. Sherwood Brown, MD PhD
||UT Southwestern Medical Center
||University of Texas Southwestern Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 4, 2007
|Results First Received:
||October 23, 2015
||April 1, 2016
||United States: Food and Drug Administration
Keywords provided by University of Texas Southwestern Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 23, 2016
Bipolar and Related Disorders
Anti-Infective Agents, Local
Central Nervous System Depressants
Physiological Effects of Drugs