Completed

NCT Number: NCT00223262

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

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.

Completed

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The UT Southwestern Medical Center

Dallas, Texas, 75390-8843, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamotrigine (Drug)

Drug

Primary outcomes

Rey Auditory Verbal Learning Test (RAVLT)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2005
First posted: Sep 22, 2005
Registry last updated: Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.