Depakote ER in Bipolar Depression

March 1, 2017 updated by: Terrence Ketter, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Stanford, California, United States, 94305-5723
        • Stanford University Bipolar Disorders Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Criteria:

  • Schizophrenia or schizoaffective disorder and other disorders excluded at the discretion of the investigator's discretion
  • Substance dependence within the past 3 months and abuse within the past 2 weeks prior to study.
  • Positive screen for psychoactive drugs, stimulants or drugs of abuse (excluding marijuana, 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 the investigators
  • Women pregnant or nursing, or WOCBP who do not use adequate contraception or who are judged to be unreliable in their use of contraception
  • Subjects who failed (because of inefficacy or adverse effects) an adequate trial of Depakote; eligible patient's may not have received Depakote within 30 days of screen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Depakote ER
Depakote ER up to 1500 mg/day
Depakote ER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline, 7 weeks

The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.

Higher MADRS score indicates more severe depression the overall score ranges from 0 to 60.

Usual cutoff points are:

0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression.

Baseline, 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to the Divalproex-ER in Acute Bipolar 2 Depression.
Time Frame: 7 weeks
A reduction greater than or equal to 50% in MADRS total score from baseline to the endpoint.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Terence A. Ketter, MD, Stanford University, Department of Psychiatry and Behavioral Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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