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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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 03, 2015
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs