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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Hippocampal Atrophy Due to Corticosteroid; Hypomania Due to Corticosteroid Use; Memory Impairment Due to Corticosteroid Use

Treatments: Drug: Lamotrigine (Drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00223262

LMC-R62

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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