Clinical trial NCT00194116: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2005-09-19
Enrollment: 54
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Acute phase (week0-week6)
Secondary outcomes:
measure: Change in Young Mania Rating Scale (YMRS) Total Score
timeFrame: Acute phase (week0-week6)
measure: Change in General Behavior Inventory (GBI) Depression Scale Score
timeFrame: Acute phase (week0-week6)
measure: Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score
timeFrame: Acute phase (week0-week6)
measure: Change in Short Form Health Survey (SF-36) Physical Component Summary Score
timeFrame: Acute phase (week0-week6)
measure: Change in Short Form Health Survey (SF-36) Mental Component Summary Score
timeFrame: Acute phase (week0-week6)
measure: Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
timeFrame: Acute phase (week0-week6)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: Case Western Reserve University / University Hospitals of Cleveland
name: Keming Gao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.