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
|Condition or disease||Intervention/treatment||Phase|
|Depression, Bipolar||Drug: Depakote ER||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Depakote ER in Bipolar Depression|
|Study Start Date :||January 2004|
|Primary Completion Date :||January 2009|
|Study Completion Date :||January 2009|
Experimental: Depakote ER
Depakote ER up to 1500 mg/day
Drug: Depakote ER
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186186
|United States, California|
|Stanford University Bipolar Disorders Clinic|
|Stanford, California, United States, 94305-5723|
|Study Director:||Terence A. Ketter, MD||Stanford University, Department of Psychiatry and Behavioral Sciences|