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Generated: December 18, 2018

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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.
NCT00004817 Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures Completed Harborview Injury Prevention and Research Center Phase 3 OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury. II. Determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Valproate Sodium

Condition Name

Condition Name for Valproate Sodium
Intervention Trials
Epilepsy 7
Bipolar Disorder 6
Schizophrenia 4
Mania 3
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Condition MeSH

Condition MeSH for Valproate Sodium
Intervention Trials
Epilepsy 8
Bipolar Disorder 8
Psychotic Disorders 5
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
China 2
Austria 2
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Trials by US State

Trials by US State for Valproate Sodium
Location Trials
New York 2
Maryland 2
Florida 2
Washington 1
Pennsylvania 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 7
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Valproate Sodium
Clinical Trial Phase Trials
Completed 23
Unknown status 5
Recruiting 5
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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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 2
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Sponsor Type

Sponsor Type for Valproate Sodium
Sponsor Trials
Other 46
Industry 11
NIH 5
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