Phase 3
N=54
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00194116 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -9.64; -5.32 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Divalproex Sodium ER (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-9.64; -5.32 | — |
| SECONDARY Change in Young Mania Rating Scale (YMRS) Total Score |
-0.54; -0.46 | — |
| SECONDARY Change in General Behavior Inventory (GBI) Depression Scale Score |
-11.56; 0.9 | — |
| SECONDARY Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score |
-7.2; -6.8 | — |
| SECONDARY Change in Short Form Health Survey (SF-36) Physical Component Summary Score |
-3.4; -4.2 | — |
| SECONDARY Change in Short Form Health Survey (SF-36) Mental Component Summary Score |
17.9; 13.5 | — |
| SECONDARY Change in Hamilton Anxiety Rating Scale (HAMA) Total Score |
-4.6; -3.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT00194116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.