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

This study has been completed.

First Received on September 16, 2005. Last Updated on November 24, 2010 History of Changes

Sponsor:	Beth Israel Medical Center
Information provided by:	Beth Israel Medical Center
ClinicalTrials.gov Identifier:	NCT00206778

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 II

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

Drug Information available for: Divalproex sodium Lamotrigine Valproic acid Valproate Sodium

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 February 09, 2012