Study of Depakote ER for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
Summary
This is an open-labeled study of Divalproex Sodium Extended Release (Depakote ER), testing its efficacy for the treatment of mania in children between the ages of 6-12 who have been diagnosed with Bipolar I, Bipolar II, and Bipolar Spectrum Disorders. This is an exploratory, pilot study, seeking to determine whether Divalproex Sodium Extended Release is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder, and the study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Description
Initial clinical evidence suggests that Divalproex Sodium may play a therapeutic role in the management of pediatric bipolar disorder. Its new Extended Release formulation offers the advantage of once a day dosing. Although the precise mechanisms by which Divalproex Sodium exerts its therapeutic effects remains unknown, it has been suggested that its activity may be related to increased brain concentrations of gamma-aminobutyric acid (GABA). Although the shorter acting formulation Divalproex Sodium is FDA approved for the treatment of adult bipolar disorder, its Extended Release formulation is currently only FDA approved for adults for the prophylactic treatment of migraine headaches and has not yet been studied in patients with mania. Three studies of Divalproex Sodium have documented safety and efficacy of this compound, as well as superiority over placebo, in the treatment of adults with bipolar disorder.
This medication has not, however, been adequately investigated in children. The proposed study includes 1) an 8-week acute period, during which participants are observed during weekly visits, and up to an 8-month extension period, during which participants see a study clinician on a monthly basis, to document the response rate 2) assessment of the impact of Divalproex Sodium Extended Release on functional capacities (quality of life, psychosocial function) and cognition, 3) careful assessment of safety and tolerability.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Bipolar Disorder
Intervention
divalproex sodium extended release
Location
Massachusetts General Hospital
Cambridge
Massachusetts
United States
02138
Status
Completed
Source
Massachusetts General Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00181727
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Sodium, Dietary
Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.
Lithium
An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight 6.94. Salts of lithium are used in treating BIPOLAR DISORDER.
Retinal Bipolar Cells
INTERNEURONS of the vertebrate RETINA containing two processes. They receive inputs from the RETINAL PHOTORECEPTOR CELLS and send outputs to the RETINAL GANGLION CELLS. The bipolar cells also make lateral connections in the retina with the RETINAL HORIZONTAL CELLS and with the AMACRINE CELLS.
Sodium Isotopes
Stable sodium atoms that have the same atomic number as the element sodium, but differ in atomic weight. Na-23 is a stable sodium isotope.
Clinical Trials
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder,...
The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatme...
Divalproex ER vs. Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder
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Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder
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PubMed Articles
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OBJECTIVES: The goal of this study was to investigate the safety and efficacy in preventing relapse of a mood episode in recently manic or mixed episode patients with bipolar I disorder stabilized wit...
The role of quetiapine extended release in the treatment of bipolar depression.
Bipolar disorder is a common, recurrent, and chronic condition associated with significant morbidity and reduced longevity mainly due to the depressive pole of the illness. Despite the great need for...
A Head-to-Head Comparison of Risperidone and Divalproex for Treatment of Pediatric Bipolar Disorder.
Increased thalamic phospholipid concentration evident in bipolar I disorder.
Bipolar disorder is characterised by changes in brain metabolites, as measured by (1)H-MRS. However, there is no consistent metabolic profile for bipolar disorder, which includes changes in N-acetyl-a...
