Hippocampal Atrophy Due to Corticosteroid, Hypomania Due to Corticosteroid Use, Memory Impairment Due to Corticosteroid Use
Conditions
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.
Interventions
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lamotrigine Lamotrigine was initiated at 25 mg/day for 2 weeks, increased to 50 mg/day for 2 weeks, and then increased in 50 mg/day increments weekly to a dose of 400 mg/day at week 10 using a fixed dosing schedule. | 8 |
| Placebo Matched placebo identical in appearance to the active drug. | 11 |
| Total | 19 |
Baseline characteristics
| Characteristic | Lamotrigine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 11.2 | 47.4 years STANDARD_DEVIATION 13.3 | 46.0 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 8 participants | 11 participants | 19 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 11 |
| other Total, other adverse events | 0 / 8 | 0 / 11 |
| serious Total, serious adverse events | 0 / 8 | 0 / 11 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lamotrigine | Rey Auditory Verbal Learning Test (RAVLT) | 46.1 T-scores | Standard Deviation 15 |
| Placebo | Rey Auditory Verbal Learning Test (RAVLT) | 40.1 T-scores | Standard Deviation 11 |