Overview

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