Quetiapine for Bipolar Disorder and Alcohol Dependence (NCT00457197) | Clinical Trial Compass
CompletedPhase 4
Quetiapine for Bipolar Disorder and Alcohol Dependence
United States90 participantsStarted 2007-03
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 co…
What they're measuring
1
The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
Timeframe: 12 weeks
Trial details
NCT IDNCT00457197
SponsorUniversity of Texas Southwestern Medical Center