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

This study is currently recruiting participants.

Verified by Beth Israel Medical Center, September 2005

First Received: September 16, 2005 Last Updated: November 15, 2005 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:	Treatment, Randomized, Single Blind, Uncontrolled, Crossover Assignment
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:

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

Contacts

Contact: Samantha S Yard, BA	(212) 420-2204	syard@chpnet.org
Contact: Lauren Kunik, BA	(212) 844-1594	lkunik@chpnet.org

Locations

United States, New York
Beth Israel Medical Center	Recruiting
New York, New York, United States, 10003
Contact: Samantha S Yard, BA 212-420-2204 syard@chpnet.org
Contact: Lauren Kunik, BA (212) 844-1594 lkunik@chpnet.org
Principal Investigator: Igor Galynker, MD, PhD

Sponsors and Collaborators

Beth Israel Medical Center

Investigators

Principal Investigator:

Igor Galynker, MD, PhD

Beth Israel Medical Center

More Information

No publications provided

Study ID Numbers:	100-03
Study First Received:	September 16, 2005
Last Updated:	November 15, 2005
ClinicalTrials.gov Identifier:	NCT00206778 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Beth Israel Medical Center:

Mixed mania
Bipolar Disorder

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Central Nervous System Depressants
Enzyme Inhibitors
Cardiovascular Agents
Antimanic Agents

Valproic Acid
Pharmacologic Actions
Membrane Transport Modulators
Affective Disorders, Psychotic
Mental Disorders
Therapeutic Uses
Mood Disorders
Lamotrigine
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 05, 2009