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CLINICAL TRIALS PROFILE FOR VALPROATE SODIUM

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Clinical Trials for Valproate Sodium

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00000439	Drug Treatment for Alcoholics With Bipolar Disorder	Completed	University of Pittsburgh	Phase 2	The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00000439	Drug Treatment for Alcoholics With Bipolar Disorder	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00001482	New Drugs in the Treatment of Mood Disorders	Completed	National Institute of Mental Health (NIMH)	Phase 2	This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so that we examine possible clinical and biological factors predictors of response. The drugs will be given in a randomized order for six weeks each and you will not know when you are on a given one. There will be a 2-4 week "washout" period between treatments. If you respond well to one of these treatments, a longer open continuation period will be offered at the end of this study. This would involve one or both drugs in combination. A variety of rating scales and brain imaging procedures will also be offered before and during each drug evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine, however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually mild, and resolve with continued time on the drug or a decrease in dosage.

Clinical Trial Conditions for Valproate Sodium

Condition Name

Condition Name for Valproate Sodium
Intervention	Trials
Epilepsy	8
Bipolar Disorder	6
Schizophrenia	4

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Condition MeSH

Condition MeSH for Valproate Sodium
Intervention	Trials
Epilepsy	9
Bipolar Disorder	8
Disease	5

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Clinical Trial Locations for Valproate Sodium

Trials by Country

Trials by Country for Valproate Sodium
Location	Trials
United States	15
France	4
Denmark	3
Netherlands	2
Finland	2

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Trials by US State

Trials by US State for Valproate Sodium
Location	Trials
Florida	2
New York	2
Maryland	2
Georgia	1
North Carolina	1

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Clinical Trial Progress for Valproate Sodium

Clinical Trial Phase

Clinical Trial Phase for Valproate Sodium
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	8
Phase 2/Phase 3	3

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Clinical Trial Status

Clinical Trial Status for Valproate Sodium
Clinical Trial Phase	Trials
Completed	23
Not yet recruiting	6
Recruiting	6

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Clinical Trial Sponsors for Valproate Sodium

Sponsor Name

Sponsor Name for Valproate Sodium
Sponsor	Trials
Stanley Medical Research Institute	3
Abbott	3
National Institute of Mental Health (NIMH)	2

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Sponsor Type

Sponsor Type for Valproate Sodium
Sponsor	Trials
Other	49
Industry	13
NIH	5

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