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CLINICAL TRIALS PROFILE FOR DEPAKOTE ER

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Clinical Trials for Depakote Er

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00005015	Treatment of Depression in Youth With Bipolar Disorders	Terminated	National Institute of Mental Health (NIMH)	Phase 3	THIS STUDY HAS BEEN DISCONTINUED. The study is designed to evaluate the safety and efficacy of fluoxetine for treating children and adolescents with Bipolar Disorder who are experiencing an episode of major depression while being treated with a mood stabilizer. The study involves a 2-week assessment period. Patients who are on stable, therapeutic doses of lithium or valproate and continue to have depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who respond favorably to treatment will be followed openly for an 18-week continuation phase.
NCT00048802	Treatment and Outcome of Early Onset Bipolar Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
NCT00048802	Treatment and Outcome of Early Onset Bipolar Disorder	Completed	Northwell Health	Phase 4	This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
NCT00057681	Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents	Completed	National Institute of Mental Health (NIMH)	Phase 3	This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
NCT00057681	Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents	Completed	Washington University School of Medicine	Phase 3	This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
NCT00060905	An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder	Completed	Abbott	Phase 3	The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.
NCT00063362	Combination Therapy for the Treatment of Bipolar Disorders	Terminated	National Institute of Mental Health (NIMH)	Phase 3	This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.

Clinical Trial Conditions for Depakote Er

Condition Name

Condition Name for Depakote Er
Intervention	Trials
Bipolar Disorder	26
Healthy	16
Mania	4
Schizophrenia	4

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Condition MeSH

Condition MeSH for Depakote Er
Intervention	Trials
Bipolar Disorder	32
Disease	24
Mood Disorders	5
Depression	5

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Clinical Trial Locations for Depakote Er

Trials by Country

Trials by Country for Depakote Er
Location	Trials
United States	171
India	7
Canada	3
Korea, Republic of	2
France	1

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Trials by US State

Trials by US State for Depakote Er
Location	Trials
Texas	16
Ohio	14
Illinois	12
New York	11
California	10

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Clinical Trial Progress for Depakote Er

Clinical Trial Phase

Clinical Trial Phase for Depakote Er
Clinical Trial Phase	Trials
Phase 4	29
Phase 3	17
Phase 2/Phase 3	1

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Clinical Trial Status

Clinical Trial Status for Depakote Er
Clinical Trial Phase	Trials
Completed	61
Terminated	7
Unknown status	6

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Clinical Trial Sponsors for Depakote Er

Sponsor Name

Sponsor Name for Depakote Er
Sponsor	Trials
Abbott	33
National Institute of Mental Health (NIMH)	9
Dr. Reddy's Laboratories Limited	7

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Sponsor Type

Sponsor Type for Depakote Er
Sponsor	Trials
Other	64
Industry	58
NIH	16

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