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

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Divalproex Sodium ER	Divalproex Sodium ER	-

Primary Outcome Measures

Name	Time	Method
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Acute phase (week0-week6)	MADRS total scores range from 0-60, where higher scores are indicative of more depression.

Secondary Outcome Measures

Name	Time	Method
Change in Short Form Health Survey (SF-36) Mental Component Summary Score	Acute phase (week0-week6)	SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health.
Change in Young Mania Rating Scale (YMRS) Total Score	Acute phase (week0-week6)	YMRS Scores range from 0 to 60 where higher scores are indicative of more mania.
Change in General Behavior Inventory (GBI) Depression Scale Score	Acute phase (week0-week6)	GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression.
Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score	Acute phase (week0-week6)	GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms.
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score	Acute phase (week0-week6)	HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety.
Change in Short Form Health Survey (SF-36) Physical Component Summary Score	Acute phase (week0-week6)	SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health.