WithdrawnPhase 2

Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence

United States0Started 2003-06

Plain-language summary

The purpose of this study is to determine if Divalproex Sodium can be used to Treat and Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol Dependence/Abuse.

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: * MADRS \>= 20 at screen and 18 at baseline * YMRS =\< 11 at screen and baseline * DMS-IV criteria for past manic or hypomanic episode based on the SCID * DSM-VI criteria for alcohol dependence or abuse based on the SCID. * Alcohol dependence/abuse confirmed by corroboration from family member * Negative urine pregnancy test Exclusion Criteria: * Inability to give informed consent * Inability to give reliable assessment of alcohol consumption * Evidence of alcohol consumption one week prior to baseline * Liver function tests greater than 3X upper limit of normal at screen * History of active hepatitis or hepatic encephalopathy * History of pancreatitis * History of adverse reaction to divalproex sodium * History of seizure other than directly associated w/prior alcohol withdrawl * History of major head trauma with LOC \> 10 min. or skull fracture * Hisotry of hypertension or neurologic illness * If female, not practicing an effective form of birth control

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

Primary Efficacy Measures for this study are: Percent change in MADRS from baseline score to study endpoint; Percent of days heavy drinking from 120 days prescreen to study end point; and Percent of subjects successfully completing outpatient detox.

Trial details

NCT IDNCT00204503

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Bipolar I or II Depression and Alcohol Abuse or Dependence trials

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.