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CLINICAL TRIALS PROFILE FOR VALPROATE SODIUM

Clinical Trials for Valproate Sodium

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000439	Drug Treatment for Alcoholics With Bipolar Disorder	Completed	University of Pittsburgh	Phase 2	2000-10-01	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	2000-10-01	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	1995-05-01	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	1991-02-01	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.
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