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Generated: November 15, 2018

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CLINICAL TRIALS PROFILE FOR DIVALPROEX SODIUM

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Clinical Trials for Divalproex Sodium

Trial ID Title Status Sponsor Phase Summary
NCT00067262 An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents Completed Abbott Phase 3 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, manic or mixed type in children and adolescents ages 10-17 years.
NCT00108576 Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder) Completed VA Office of Research and Development Phase 3 The purposes of this study are: - To study the efficacy of divalproex in the treatment of PTSD; - To study the plasma GABA (gamma aminobutyric acid) levels before and after treatment with divalproex in PTSD.
NCT00140179 Valnoctamide in Mania Completed Stanley Medical Research Institute Phase 3 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00140179 Valnoctamide in Mania Completed Beersheva Mental Health Center Phase 3 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00145470 12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008)(COMPLETED)(P05844) Completed Merck Sharp & Dohme Corp. Phase 3 This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Divalproex Sodium

Condition Name

Condition Name for Divalproex Sodium
Intervention Trials
Healthy 16
Bipolar Disorder 14
Epilepsy 5
Autism 4
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Condition MeSH

Condition MeSH for Divalproex Sodium
Intervention Trials
Bipolar Disorder 17
Disease 11
Alcoholism 5
Migraine Disorders 4
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Clinical Trial Locations for Divalproex Sodium

Trials by Country

Trials by Country for Divalproex Sodium
Location Trials
United States 66
India 7
Norway 1
Brazil 1
Israel 1
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Trials by US State

Trials by US State for Divalproex Sodium
Location Trials
New York 6
Illinois 6
Texas 5
Virginia 4
Florida 4
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Clinical Trial Progress for Divalproex Sodium

Clinical Trial Phase

Clinical Trial Phase for Divalproex Sodium
Clinical Trial Phase Trials
Phase 4 13
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Divalproex Sodium
Clinical Trial Phase Trials
Completed 47
Unknown status 6
Withdrawn 5
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Clinical Trial Sponsors for Divalproex Sodium

Sponsor Name

Sponsor Name for Divalproex Sodium
Sponsor Trials
Abbott 12
Dr. Reddy's Laboratories Limited 7
Teva Pharmaceuticals USA 4
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Sponsor Type

Sponsor Type for Divalproex Sodium
Sponsor Trials
Industry 38
Other 33
NIH 6
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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Mallinckrodt
Healthtrust
McKesson
Farmers Insurance
AstraZeneca
Johnson and Johnson
Fuji
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