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

Phase 3CompletedNCT00194116

University Hospitals Cleveland Medical Center54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bipolar Disorder

Interventions

Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.

PlaceboDRUG

. Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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