Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT00204503
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00204503
Study Brief:
Protocol Section:
NCT00204503