Expired Study
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Cleveland, Ohio 44106


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.


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



Primary Contact:

Principal Investigator
Keming Gao, MD, PhD
Case Western Reserve University / University Hospitals of Cleveland

Backup Contact:


Location Contact:

Cleveland, Ohio 44106
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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