Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression (NCT00194116) | Clinical Trial Compass
CompletedPhase 3
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
United States54 participantsStarted 2004-09
Plain-language 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.
Who can participate
Age range
16 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Timeframe: Acute phase (week0-week6)
Trial details
NCT IDNCT00194116
SponsorUniversity Hospitals Cleveland Medical Center