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

Tracking Information

First Received Date ^ICMJE

September 15, 2005

Last Updated Date

January 27, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00223262 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Memory Impairment Due to Corticosteroid Use.
Hypomania Due to Corticosteroid Use.
Hippocampal Atrophy Due to Corticosteroid.

Intervention ^ICMJE

Drug: Lamotrigine (Drug)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00223262

Responsible Party

Study ID Numbers ^ICMJE

LMC-R62

Study Sponsor ^ICMJE

University of Texas Southwestern Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

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

The UT Southwestern Medical Center

Information Provided By

University of Texas Southwestern Medical Center

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP