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

NCT00223262 | Completed Phase 4 Results

• 1 other identifier: LMC-R62
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rey Auditory Verbal Learning Test (RAVLT)

  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.

  24 weeks

Interventions

Lamotrigine (Drug) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current Corticosteroid Use of 7 mg or more for 6+ months
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The UT Southwestern Medical Center

Dallas, Texas, 75390-8843, United States

Location

MeSH Terms

Interventions

Lamotrigine; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: E. Sherwood Brown, MD, PhD
• Organization: University of Texas Southwestern Medical Center

sherwood.brown@utsouthwestern.edu

2146456950

Study Officials

• E. Sherwood Brown, Ph.D., M.D.

  The UT Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2002
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-04

Locations

US (1)