Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Divalproex Sodium ER (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University Hospital Case Medical Center Official(s) and/or principal investigator(s): Keming Gao, MD, PhD, Principal Investigator, Affiliation: Case Western Reserve University / University Hospitals of Cleveland
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.
Clinical Details
Official title: Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcome: 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
Eligibility
Minimum age: 16 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
University Hospitals of Cleveland, Cleveland, Ohio 44106, United States
Additional Information
Starting date: September 2004
Last updated: December 1, 2014
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