Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Divalproex Sodium ER; Placebo
Intervention description: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.; . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
Intervention MeSH terms: Valproic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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