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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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