Back to resultsDouble-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Divalproex Sodium ER
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility 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
Sites / Locations
- University Hospitals of Cleveland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Divalproex Sodium ER
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
MADRS total scores range from 0-60, where higher scores are indicative of more depression.
Secondary Outcome Measures
Change in Young Mania Rating Scale (YMRS) Total Score
YMRS Scores range from 0 to 60 where higher scores are indicative of more mania.
Change in General Behavior Inventory (GBI) Depression Scale Score
GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression.
Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score
GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms.
Change in Short Form Health Survey (SF-36) Physical Component Summary Score
SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health.
Change in Short Form Health Survey (SF-36) Mental Component Summary Score
SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health.
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety.
Full Information
NCT ID
NCT00194116
First Posted
September 13, 2005
Last Updated
May 3, 2019
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00194116
Brief Title
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Official Title
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Divalproex Sodium ER
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium ER
Other Intervention Name(s)
Depakote ER
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
. 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.
Primary Outcome Measure Information:
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
MADRS total scores range from 0-60, where higher scores are indicative of more depression.
Time Frame
Acute phase (week0-week6)
Secondary Outcome Measure Information:
Title
Change in Young Mania Rating Scale (YMRS) Total Score
Description
YMRS Scores range from 0 to 60 where higher scores are indicative of more mania.
Time Frame
Acute phase (week0-week6)
Title
Change in General Behavior Inventory (GBI) Depression Scale Score
Description
GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression.
Time Frame
Acute phase (week0-week6)
Title
Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score
Description
GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms.
Time Frame
Acute phase (week0-week6)
Title
Change in Short Form Health Survey (SF-36) Physical Component Summary Score
Description
SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health.
Time Frame
Acute phase (week0-week6)
Title
Change in Short Form Health Survey (SF-36) Mental Component Summary Score
Description
SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health.
Time Frame
Acute phase (week0-week6)
Title
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
Description
HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety.
Time Frame
Acute phase (week0-week6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keming Gao, MD, PhD
Organizational Affiliation
Case Western Reserve University / University Hospitals of Cleveland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20816041
Citation
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.
Results Reference
derived
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Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
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