Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medical University of South Carolina
With
Forest Laboratories
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Adults ages 18-65
2. Meet DSM-IV criteria for current (past 90 days) alcohol dependence
3. Meet DSM-IV criteria for bipolar I or bipolar II disorder
4. Currently on a mood stabilizing medication regimen, including the use of lithium, valproic acid, lamotrigine, carbamazepine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past 30 days
5. Must be able to remain free from alcohol for at least 3 days prior to medication initiation
6. Subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments
7. Subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments
You may not be if
1. Individuals with a primary psychiatric disorder other than bipolar disorder
2. Individuals with an uncontrolled neurologic condition that could confound the results of the study
3. Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
4. Participants with creatinine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.
5. Concomitant use of other psychotropic medications not allowed per the protocol
6. Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
7. Current suicidal or homicidal risk
8. Baseline scores of \> 35 on the Montgomery Asberg Depression Rating Scale and/or \> 25 on the Young Mania Rating Scale
