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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 Hospitals of Cleveland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00194116
First received: September 13, 2005
Last updated: February 5, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
 Drug: Divalproex
Drug: Placebo Divalproex
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Acute phase (week0-week6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: September 2004
Estimated Study Completion Date: April 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Placebo Comparator: 2 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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194116

Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Abbott
Investigators
Principal Investigator: Keming Gao, MD, PhD Case Western Reserve University / University Hospitals of Cleveland
  More Information

No publications provided by University Hospitals of Cleveland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Keming Gao, MD, PhD, University Hospitals/Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00194116     History of Changes
Other Study ID Numbers: UHHS 08-03-07
Study First Received: September 13, 2005
Last Updated: February 5, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013