- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00457197
Quetiapine for Bipolar Disorder and Alcohol Dependence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Psychoneuroendocrine Research Program
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inventory of Depressive Symptomatology-Self Report (IDS-SR)
Time Frame: 12 weeks
|
IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode. Score: Minimum: 0 Maximum: 84 Lower score associated with better outcome |
12 weeks
|
Young Mania Rating Scale (YMRS)
Time Frame: 12 weeks
|
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). Score: Minimum: 0 Maximum: 60 Lower score associated with better outcome |
12 weeks
|
Percent of Heavy Drinking Days
Time Frame: 12 weeks
|
12 weeks
|
|
Gamma-glutamyltransferase (GGT)
Time Frame: 12 weeks
|
GGT is a liver enzyme measurement (IU/I)
|
12 weeks
|
Aspartate Aminotransferase (AST)
Time Frame: 12 weeks
|
AST is a liver enzyme measurement (IU/I)
|
12 weeks
|
Alanine Aminotransferase (ALT)
Time Frame: 12 weeks
|
ALT is a liver enzyme measurement (IU/I).
|
12 weeks
|
Hamilton Rating Scale for Depression (HRSD)
Time Frame: 12 weeks
|
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+). Scale: Minimum: 0 Maximum: 50 Lower score associated with better outcome |
12 weeks
|
Penn Alcohol Craving Scale (PACS)
Time Frame: 12 weeks
|
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 Score: Minimum: 0 Maximum: 30 Lower score associated with better outcome. |
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: E. Sherwood Brown, MD PhD, UT Southwestern Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Alcohol-Related Disorders
- Substance-Related Disorders
- Bipolar and Related Disorders
- Alcoholism
- Disease
- Bipolar Disorder
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- 112006-046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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