Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

This study is currently recruiting participants.

Verified by The University of Texas Health Science Center at San Antonio, April 2007

First Received: September 13, 2005 Last Updated: April 24, 2007 History of Changes

Sponsor:	The University of Texas Health Science Center at San Antonio
Collaborator:	GlaxoSmithKline
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00223509

Purpose

To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder.
To evaluate the efficacy and of a combination of LAM+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder

Condition	Intervention	Phase
Bipolar Disorder	Drug: Lamotrigine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

Primary efficacy, during the first 10 weeks (acute phase) of the study, will be assessed by the proportion of patients achieving a 50% reduction of their depressive symptoms as assessed by the MADRS and a GAF
MADRS minus 14, GAF score 51. Secondary measures will include the YMRS, and CGI Bipolar version.
Efficacy, during the maintenance phase of the study, will be assessed by the proportion of patients able to maintain a response, at the end of the study, as defined by
MADRS total score of <14, GAF score 51. Secondary measures will include the YMRS, and CGI Bipolar version.

Secondary Outcome Measures:

Secondary measures will include the YMRS, and CGI Bipolar version.

Estimated Enrollment:	50
Study Start Date:	August 2005
Estimated Study Completion Date:	October 2010

Detailed Description:

To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder.
To evaluate the efficacy and of a combination of LAM+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder

Eligibility

Ages Eligible for Study:	13 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

In order to be included in the study patient must meet criteria A, C, D, E, F, G plus any 1 of the 3 criteria listed in section B.

A. Patients meeting DSM-IV diagnosis of bipolar disorder, I or II

Patients meeting DSM-IV diagnostic criteria for a manic/hypomanic episode with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or
Patients meeting DSM-IV symptomatic criteria for a hypomanic/manic episode for a period of 2 days or longer, with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or
Patients meeting DSM-IV criteria for a depressive episode associated with at least three DSM-IV manic/hypomanic symptoms

C.MADRS of ≥14

D.YMRS of ≥ 14

E. Age 13years to 75 years

F. Male or female

G. Outpatient

Exclusion Criteria:

illness precluding the use of LAM
Alcohol/drug dependence in the past one month
patients with a history of a rash on LAM
CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
patients currently taking LAM

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223509

Contacts

Contact: Martha - Dahl, R.N.	210-567-5501	dahlml@uthscsa.edu
Contact: Vivek - Singh, MD	210-567-5479	singhv@uthscsa.edu

Locations

United States, Texas
University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78229
Contact: Martha _ Dahl, RN 210-567-5501 dahlml@uthscsa.edu
Univ of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78229
Contact: martha - dahl

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

GlaxoSmithKline

Investigators

Principal Investigator:	Vivek - Singh, MD	University of Texas
Principal Investigator:	Charles L Bowden, MD	University of Texas

More Information

No publications provided

Study ID Numbers:	0340013418
Study First Received:	September 13, 2005
Last Updated:	April 24, 2007
ClinicalTrials.gov Identifier:	NCT00223509 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:

mixed mania
lamotrigine

Additional relevant MeSH terms:

Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Affective Disorders, Psychotic

Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Lamotrigine
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010