Back to resultsDepakote-ER for Depressive and Bipolar Depression
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Depakote-ER
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS < 12; MADRS > 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics Exclusion Criteria: Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality
Sites / Locations
Outcomes
Primary Outcome Measures
Anxiety and Depressive Symptom severity
Secondary Outcome Measures
Full Information
NCT ID
NCT00226343
First Posted
September 12, 2005
Last Updated
April 17, 2017
Sponsor
Cambridge Health Alliance
Collaborators
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00226343
Brief Title
Depakote-ER for Depressive and Bipolar Depression
Official Title
Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cambridge Health Alliance
Collaborators
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.
Detailed Description
Study is 6 weeks long, with 7 clinical visits.
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 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Depakote-ER
Primary Outcome Measure Information:
Title
Anxiety and Depressive Symptom severity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS < 12; MADRS > 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics
Exclusion Criteria:
Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T Dunn, MD, PhD
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18162014
Citation
Ghaemi SN, Gilmer WS, Goldberg JF, Zablotsky B, Kemp DE, Kelley ME, Bauer AD, Fleck J, Filkowski MM, Stan VA, Dunn RT. Divalproex in the treatment of acute bipolar depression: a preliminary double-blind, randomized, placebo-controlled pilot study. J Clin Psychiatry. 2007 Dec;68(12):1840-4. doi: 10.4088/jcp.v68n1203.
Results Reference
derived
Learn more about this trial
Depakote-ER for Depressive and Bipolar Depression
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