Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression. Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks. This six-week double-blind treatment period is followed by an open-label treatment period of six months duration. This study is sponsored by Abbott Laboratories.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Abbott
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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