Reversing Corticosteroid Induced Memory Impairment
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|ClinicalTrials.gov Identifier: NCT01142310|
Recruitment Status : Completed
First Posted : June 11, 2010
Results First Posted : August 27, 2018
Last Update Posted : August 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Memory Impairment||Drug: Lamotrigine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Reversing Corticosteroid Induced Memory Impairment|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: Lamotrigine
Dose titration: begin at Baseline at 25mg PO QD for two weeks. Increase to 50mg PO QD at Week 2 for two weeks. Increase to 100mg PO QD at Week 4. Increase to 150mg PO QD at Week 5. Increase to 200mg PO QD at Week 6. Increase to 250mg PO QD at Week 7. Increase to 300mg PO QD at Week 8. Increase to 350mg PO QD at Week 9. Increase to 400mg PO QD at Week 10. Stay at 400mg PO QD from Week 10 to Week 48.
Lamotrigine will be initiated at 25 mg/day and upwardly titrated to a dose of 400 mg/day over 10 weeks.
Other Name: Lamictal
Placebo Comparator: Placebo
Placebo administered the same as the Lamotrigine just described.
- The Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 48 weeks ]The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. A higher score reflects better performance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142310
|United States, Texas|
|Parkland Health and Hospital System (Asthma, Allergy, & Arthritis Clinics)|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||E. Sherwood Brown, M.D., Ph.D.||UT Southwestern Medical Center|