A Phase 4 interventional study of Lamotrigine (Drug) in Memory Impairment Due to Corticosteroid Use, Hypomania Due to Corticosteroid Use and Hippocampal Atrophy Due to Corticosteroid, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by University of Texas Southwestern Medical Center · Phase 4 and Interventional
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.
Exclusion Criteria:
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.
Time frame: 24 weeks
| Milestone | Lamotrigine | Placebo |
|---|---|---|
| Started | 16 | 12 |
| Completed | 8 | 11 |
| Not completed | 8 | 1 |
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.
| T-scores | Lamotrigine | Placebo |
|---|---|---|
| Rey Auditory Verbal Learning Test (RAVLT) | 46.1 ± 15.0 | 40.1 ± 11.0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lamotrigine | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | Lamotrigine | Placebo | Total |
|---|---|---|---|
| Mean | 44.6 ± 11.2 | 47.4 ± 13.3 | 46.0 ± 12.3 |
| Sex: Female, Male(Participants) | Lamotrigine | Placebo | Total |
|---|---|---|---|
| Female | 1 | 3 | 4 |
| Male | 7 | 8 | 15 |
| Region of Enrollment(participants) | Lamotrigine | Placebo | Total |
|---|---|---|---|
| United States | 8 | 11 | 19 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center