Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients
Information source: University of Texas Southwestern Medical Center
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Memory Impairment Due to Corticosteroid Use.; Hypomania Due to Corticosteroid Use.; Hippocampal Atrophy Due to Corticosteroid.
Intervention: Lamotrigine (Drug) (Drug)
Phase: Phase 4
Status: No longer recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s):
E. Sherwood Brown, Ph.D., M.D., Principal Investigator, Affiliation: The UT Southwestern Medical Center
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.
Clinical Details
Study design: Interventional, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): 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
Locations and Contacts
The UT Southwestern Medical Center, Dallas, Texas 75390-8843, United States
Additional Information
Last updated: October 19, 2005
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