Valnoctamide in Mania

NCT00140179 | Completed Phase 3 DMC

• 1 other identifier: BMHC-3658
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Mania; Schizoaffective Disorder, Manic Type

Keywords

valnoctamide; teratogenicity; double-blind; mania

Outcome Measures

Primary Outcomes (3)

• Brief Psychiatric Rating Scale

• Young Mania Rating Scale

• Clinical Global Impression

Interventions

valnoctamide DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beersheva Mental Health Center: lead
• Stanley Medical Research Institute: collaborator

Study Sites (3)

Hemek Medical Center

Afula, Israel

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Beersheva Mental Health Center

Beersheva, Israel

Location

MeSH Terms

Conditions

Mania; Psychotic Disorders; Teratogenesis

Interventions

valnoctamide

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes

Study Officials

• RH Belmaker, MD

  Ben Gurion University of the Negev + Beersheva Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: September 1, 2004
• Study Completion: May 1, 2008
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

IL (3)