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

Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Divalproex Sodium ER (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University Hospital Case Medical Center

Official(s) and/or principal investigator(s):
Keming Gao, MD, PhD, Principal Investigator, Affiliation: Case Western Reserve University / University Hospitals of Cleveland


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary outcome: Change from baseline Young Mania Rating Scale (YMRS), GBI Depression and Hypomanic/Biphasic scores, Short Form Health Survey (SF-36), and Hamilton Anxiety Scale (HAM-A) during acute and extension phases


Minimum age: 16 Years. Maximum age: 65 Years. Gender(s): Both.


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


- Subject has any cocaine, hallucinogens, opiates, crystal methamphetamine, or MMDA

abuse within 3 months of study entry

Locations and Contacts

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States
Additional Information

Starting date: September 2004
Last updated: December 1, 2014

Page last updated: August 20, 2015

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