Status:
COMPLETED
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Abbott
Conditions:
Bipolar Disorder
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
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 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00194116
Start Date
September 1 2004
End Date
February 1 2008
Last Update
July 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106