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Depakote ER in Bipolar Depression

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ClinicalTrials.gov Identifier: NCT00186186
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborators:
Abbott
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Terrence Ketter, Stanford University

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE May 12, 2014
Results First Posted Date  ICMJE April 12, 2017
Last Update Posted Date April 12, 2017
Study Start Date  ICMJE January 2004
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Depakote ER in Bipolar Depression
Official Title  ICMJE Depakote ER in Bipolar Depression
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression, Bipolar
Intervention  ICMJE Drug: Depakote ER
Depakote ER
Study Arms  ICMJE Experimental: Depakote ER
Depakote ER up to 1500 mg/day
Intervention: Drug: Depakote ER
Publications * Wang PW, Nowakowska C, Chandler RA, Hill SJ, Nam JY, Culver JL, Keller KL, Ketter TA. Divalproex extended-release in acute bipolar II depression. J Affect Disord. 2010 Jul;124(1-2):170-3. doi: 10.1016/j.jad.2009.10.021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
28
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
50
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00186186
Other Study ID Numbers  ICMJE 79130
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Terrence Ketter, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE
  • Abbott
  • National Alliance for Research on Schizophrenia and Depression
Investigators  ICMJE
Study Director: Terence A. Ketter, MD Stanford University, Department of Psychiatry and Behavioral Sciences
PRS Account Stanford University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP