Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients

This study has been completed.

First Received on September 15, 2005. Last Updated on August 2, 2011 History of Changes

Sponsor:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00223262

Purpose

The purpose of this study is to determine if lamotrigine therapy is associated with improvement in mood, memory and hippocampal size and function in patients receiving chronic corticosteroid therapy. Standard care for mood changes associated with corticosteroid therapy, if severe, includes antidepressants or other medications which can influence mood. No therapies, other than dose reduction or discontinuation, are currently available for memory loss associated with corticosteroid treatment. However, very little information is available on the treatment of either mood or memory changes associated with corticosteroid treatment, thus the proposed project may improve standard care.

Condition	Intervention	Phase
Memory Impairment Due to Corticosteroid Use. Hypomania Due to Corticosteroid Use. Hippocampal Atrophy Due to Corticosteroid.	Drug: Lamotrigine (Drug)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind

Resource links provided by NLM:

MedlinePlus related topics: Memory

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Study Start Date:	August 2002
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Current Corticosteroid Use of 7 mg or more for 6+ months
18-65 years of age

Exclusion Criteria:

Primarily non-English speaking
Pregnant/nursing woman
Currently taking Depakote
Currently taking Rifampin
Has diagnosis of major depressive disorder, schizophrenia, PTSD, bipolar I or bipolar II (not related to corticosteroid use)
Diseases with CNS involvement
Is to start a brief steroid taper
History of Alcohol/drug abuse/dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223262

Locations

United States, Texas
The UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8843

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator:

E. Sherwood Brown, Ph.D., M.D.

The UT Southwestern Medical Center

More Information

No publications provided

Responsible Party:	Sherwood Brown, UT Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier:	NCT00223262 History of Changes
Other Study ID Numbers:	LMC-R62
Study First Received:	September 15, 2005
Last Updated:	August 2, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Memory Disorders
Atrophy
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Lamotrigine

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012