Reversing Corticosteroid-Induced Memory Impairment. November, 2009

Study ID
STU 082010-100

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Nasreen Sayed
214-645-6965
nasreen.sayed@utsouthwestern.edu

Principal Investigator
Edson Brown

Summary

a total of 50 medically stable outpatients with asthma receiving chronic oral corticosteroid therapy will be enrolled locally in a 60-week randomized, double-blind, placebo-controlled trial of lamotrigine. all participants, including screen failures, will sign an iRB-approved informed consent form. including screen failures, the number of signed consents may be as high as 75. at the Baseline visit, patients will be randomized on a 1:1 basis, and receive, either lamotrigine or matching placebo, both orally administered. Between-group differences (lamotrigine vs. placebo) in declarative memory as assessed by the RaVLT will be the primary clinical outcome. additional outcomes will be analyses of other cognitive domains sensitive to hippocampal functioning and working memory, spectroscopy, and relationships between corticosteroid dose and duration and outcome measures. Hippocampal and amygdalar volume will also be explored. a structured clinical interview for DSM-iV (SCiD-CV) will be administered at baseline to assess past and current psychiatric diagnoses that are exclusionary. The RaVLT, Sternberg Memory Task (SMT), Logical Memory scale from the Wechsler Memory Scale iii, and RMCPT, Stroop Test, Trail Making Test, Wechsler Test of adult Reading, and everyday Memory Questionnaire will be administered to assess cognition. Mood will be assessed using the 16-item Quick inventory of Depressive Symptomatology x ClinicianRated (QiDS-C16), Young Mania Rating Scale, and internal State Scale. Blood will be drawn (approximately two tablespoons) at the baseline visit to assess plasma prednisone, prednisolone (the active metabolite of prednisone), and cortisol levels. in addition, urine pregnancy tests will be given to females who are of child-bearing age. Participants will also be contacted by phone for brief follow-up visits; women of childbearing potential will be asked about their last menstrual period.

Participant Eligibility


* Physician diagnosis of any chronic medical condition requiring treatment with oral corticosteroids confirmed by chart review and/or patients assessment by the P.I. or co-I.s

* Receiving prednisone therapy of at least 5 mg of prednisone daily for at least 6 months with anticipated treatment for >= 15 additional months. This is a dose and duration that is frequently associated with the development of systemic side effects (e.g., Cushingoid features).

* Men and Women of All Races Age 18-70 years. Older patients are excluded to minimize the possibility of enrolling participants with early dementias and to minimize sample heterogeneity.