Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
This study has been completed.
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospital Case Medical Center
First received: September 13, 2005
Last updated: December 1, 2014
Last verified: December 2014
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.
Drug: Divalproex Sodium ER
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2007 (Final data collection date for primary outcome measure)
Experimental: Divalproex Sodium ER
Drug: Divalproex Sodium ER
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.
Other Name: Depakote ER
Placebo Comparator: Placebo
. 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.
|Ages Eligible for Study:
||16 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194116
|University Hospitals of Cleveland
|Cleveland, Ohio, United States, 44106 |
University Hospital Case Medical Center
||Keming Gao, MD, PhD
||Case Western Reserve University / University Hospitals of Cleveland
No publications provided by University Hospital Case Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. doi: 10.4088/JCP.09m05570gre. Epub 2010 Aug 24.
||Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospital Case Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||December 1, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 30, 2015
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs