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

Completed · Phase 4

Conditions studied: Memory Impairment Due to Corticosteroid Use, Hypomania Due to Corticosteroid Use, Hippocampal Atrophy Due to Corticosteroid

In brief

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.

Key facts

Study ID

NCT00223262

Run by

University of Texas Southwestern Medical Center

People needed

28

Starts

2002-08-01

Expected to finish

2005-09-01

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• The UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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