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Valnoctamide in Mania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140179
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : November 25, 2009
Stanley Medical Research Institute
Information provided by:
Beersheva Mental Health Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Mania Schizoaffective Disorder, Manic Type Drug: valnoctamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Valnoctamide as a Valproate Substitute With Low Teratogenic Potential: Double-Blind Controlled Clinical Trial
Study Start Date : September 2004
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Brief Psychiatric Rating Scale
  2. Young Mania Rating Scale
  3. Clinical Global Impression

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 18-60
  • Males or females
  • DSM-IV criteria for mania or schizoaffective disorder, manic type
  • Minimal Young Mania Scale = 20
  • Admittance to hospital within previous 72 hours

Exclusion Criteria:

  • Any active physical illness
  • Pregnancy
  • Drug or alcohol abuse
  • Suicidal or violent ideation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140179

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Hemek Medical Center
Afula, Israel
Barzilai Medical Center
Ashkelon, Israel
Beersheva Mental Health Center
Beersheva, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Stanley Medical Research Institute
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Study Director: RH Belmaker, MD Ben Gurion University of the Negev + Beersheva Mental Health Center
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Responsible Party: Yuly Bersudsky, Ben Gurion University Identifier: NCT00140179    
Other Study ID Numbers: BMHC-3658
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009
Keywords provided by Beersheva Mental Health Center:
Additional relevant MeSH terms:
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Psychotic Disorders
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Bipolar and Related Disorders