Valnoctamide in Mania

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00140179
First received: August 31, 2005
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Mania
Schizoaffective Disorder, Manic Type
Drug: valnoctamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Valnoctamide as a Valproate Substitute With Low Teratogenic Potential: Double-Blind Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale
  • Young Mania Rating Scale
  • Clinical Global Impression

Estimated Enrollment: 80
Study Start Date: September 2004
Study Completion Date: May 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140179

Locations
Israel
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
Investigators
Study Director: RH Belmaker, MD Ben Gurion University of the Negev + Beersheva Mental Health Center
  More Information

No publications provided

Responsible Party: Yuly Bersudsky, Ben Gurion University
ClinicalTrials.gov Identifier: NCT00140179     History of Changes
Other Study ID Numbers: BMHC-3658
Study First Received: August 31, 2005
Last Updated: November 23, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:
valnoctamide
teratogenicity
double-blind
mania

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on April 17, 2014