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

University Hospitals (UH)

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Placebo

Drug: Divalproex Sodium ER

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00194116

UHHS 08-03-07

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

16 to 65 years old

Volunteers

Accepts Healthy Volunteers

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