Depakote ER in Bipolar Depression

Last updated: March 1, 2017
Sponsor: Stanford University
Overall Status: Completed

Phase

4

Condition

Depression

Bipolar Disorder

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00186186
79130
  • Ages 18-99
  • All Genders

Study Summary

The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar depression and to evaluate metabolic and GABA changes with Depakote ER administration using PET and MRI/MRS brain imaging techniques.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Bipolar I, II or NOS currently suffering from depression

  • Both: both female and male participants are being studied

  • Adults 18 years and older of any race

Exclusion

Exclusion Criteria:

  • Schizophrenia or schizoaffective disorder and other disorders excluded at thediscretion of the investigator's discretion

  • Substance dependence within the past 3 months and abuse within the past 2 weeks priorto study.

  • Positive screen for psychoactive drugs, stimulants or drugs of abuse (excludingmarijuana, as long as dependence and abuse are ruled out according to DSM-IV)

  • Significant risk harm to self or others based on history and mental status exam

  • Clinically significant or unstable medical condition

  • Unstable thyroid pathology and treatment initiated or altered within the past 3 months

  • Clinically significant abnormal laboratory test results, vital signs, as judged by theinvestigators

  • Women pregnant or nursing, or WOCBP who do not use adequate contraception or who arejudged to be unreliable in their use of contraception

  • Subjects who failed (because of inefficacy or adverse effects) an adequate trial ofDepakote; eligible patient's may not have received Depakote within 30 days of screen

Study Design

Total Participants: 28
Study Start date:
January 01, 2004
Estimated Completion Date:
January 31, 2009

Study Description

Mood disorders are important public health problems. Bipolar disorder is a major psychiatric disorder characterized by mood cycles alternating between mania and depression and affects approximately 1% of the population. Most patients are treated beginning in the early twenties and then embark on a course marked by multiple recurrences, hospitalizations, and encounters with legal authorities. These disorders inflict substantial morbidity which yields important deficits in occupational and interpersonal function. The risk of suicide in mood disorders may be as high as 10%.

Although the outlook for recovery from acute manic or depressive episodes is generally excellent, the long-term prognosis of the disorder varies tremendously across the patient population. The introduction of lithium, anticonvulsants and atypical antipsychotics significantly changes the outlook for bipolar disorder, with some individuals on chronic treatment attaining complete remission and indefinite prophylaxis against mood episodes. However, such optimum outcomes may be limited to as few as one-third to one-half of all treated patients. The remaining experiences various combinations of breakthrough mood episodes, including chronic mood instability, persistent depression, and rapid cycling.

Very little research has been conducted with bipolar disorder, and no medications have an FDA indication to treat bipolar depression. Previous studies suggest that Depakote is promising in the treatment of mixed and depressed episodes of bipolar disorder. This study utilizes the extended release formulation of divalproex sodium, with demonstrated increased tolerability.

We propose investigating safety, tolerability and efficacy of Depakote ER monotherapy in Bipolar I, II or NOS depression, and monitoring associated changes in brain GABA levels. In addition, we intend to evaluate and assess the differences between brain metabolic rate and GABA levels in bipolar disorder patients and healthy volunteers.

Connect with a study center

  • Stanford University Bipolar Disorders Clinic

    Stanford, California 94305-5723
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.