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

Phase 4

Completed

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

• Registration Number: NCT00223262
• Lead Sponsor: University of Texas Southwestern Medical Center

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

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-22
• Results First Submitted: 2019-01-14
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-12
• Last Update Submitted: 2019-04-12
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rey Auditory Verbal Learning Test (RAVLT)	24 weeks	Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. On completion of Trial 5, an interference list of 15 words (List B) is presented, followed by a free recall test of that list. After a 20-min delay, the examinee is again required to recall the words from list A - this is called the delay raw score. The raw scores on both the total recall and the delay trials (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.

Trial Locations

Locations (1)

The UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States