Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospitals Cleveland Medical Center
With
Abbott
Age
16–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Subject must give consent to participate in the study and sign and date the IRB approved written informed consent form prior to the initiation of any study procedures
Subject must be between the ages of 18 and 70
Subject must have a diagnosis of bipolar I or II.
Subject must be currently depressed as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
Subject must have a baseline Montgomery-Asberg Depression Scale (MADRS) score of \>19 and Young Mania Rating Scale (YMRS) score of \<12
Women of childbearing potential must be nonpregnant/nonlactating and using adequate contraception if sexually active
Subject must not be using any concomitant psychotropic medications during the acute phase except prn benzodiazepines
You may not be if
Subjects lacks the capacity to provide informed consent
Subject has currently or previously used divalproex or Dvpx-ER
Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
Subject has any alcohol, cocaine, or cannabis dependence within 3 months of study entry
Subject has any cocaine, hallucinogens, opiates, crystal methamphetamine, or MMDA abuse within 3 months of study entry
