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Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00206778
First received: September 16, 2005
Last updated: November 24, 2010
Last verified: November 2010
History of Changes
  Purpose

We are comparing the efficacy of Lamotrigine to that of Standard of Care Sodium Valproate for the treatment of Mixed Mania. The study hypothesis is that Lamotrigine will be more efficative for treating mixed mania in patients with Bipolar Disorder.


Condition Intervention Phase
Mixed Mania Bipolar Disorder
 Drug: Lamotrigine
Drug: Sodium Valproate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Open-Label 6 Month Acute and Maintenance Trial of Lamotrigine vs. Standard of Care Sodium Valproate Monotherapy for Treatment of Mixed Mania.

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Estimated Enrollment: 36
Study Start Date: July 2003
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, ages 18-65.
  • Ability to sign an informed consent
  • Diagnosis of Bipolar Mood Disorder I, manic episode.
  • Mania Rating Scale (MRS) score of at least 11
  • HDRS score of at least 18
  • Global Assessment Scale (GAS) scores more than 60.

Exclusion Criteria:

  • Alcohol or substance abuse within the last 6 months
  • Current diagnosis of Obsessive-Compulsive Disorder
  • Current diagnosis of Schizophrenia or Schizoaffective Disorder
  • Previous adverse reaction or allergies to lamotrigine or sodium valproate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206778

Locations
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Igor Galynker, MD, PhD Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Igor Galynker, MD, Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00206778     History of Changes
Other Study ID Numbers: 100-03
Study First Received: September 16, 2005
Last Updated: November 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Medical Center:
Mixed mania
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lamotrigine
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013