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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University Hospital Case Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00194116
First received: September 13, 2005
Last updated: February 5, 2008
Last verified: February 2008

September 13, 2005
February 5, 2008
September 2004
October 2007   (final data collection date for primary outcome measure)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Acute phase (week0-week6) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00194116 on ClinicalTrials.gov Archive Site
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 [ Time Frame: Acute and Extenstion Phases ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Divalproex
    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.
  • Drug: Placebo Divalproex
    . 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.
  • Experimental: 1
    Intervention: Drug: Divalproex
  • Placebo Comparator: 2
    Intervention: Drug: Placebo Divalproex
Muzina DJ, Gao K, Kemp DE, Khalife S, Ganocy SJ, Chan PK, Serrano MB, Conroy CM, Calabrese JR. Acute efficacy of divalproex sodium versus placebo in mood stabilizer-naive bipolar I or II depression: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):813-9. Epub 2010 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
April 2008
October 2007   (final data collection date for primary outcome measure)

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
Both
16 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00194116
UHHS 08-03-07
Not Provided
Keming Gao, MD, PhD, University Hospitals/Case Western Reserve University
University Hospital Case Medical Center
Abbott
Principal Investigator: Keming Gao, MD, PhD Case Western Reserve University / University Hospitals of Cleveland
University Hospital Case Medical Center
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP