Status:
COMPLETED
Reversing Corticosteroid Induced Memory Impairment
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Memory Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Medically stable outpatients receiving chronic oral corticosteroid therapy were enrolled in a 48-week randomized, double-blind, placebo-controlled, parallel-group, trial of lamotrigine.
Detailed Description
Stress and corticosteroid exposure are associated with changes in both the human and animal hippocampus. An extensive literature suggests that corticosteroid-induced changes in the hippocampus are, in...
Eligibility Criteria
Inclusion
- 18-70 years old
- English-speaking men and women
- Physician diagnosis of any chronic medical condition requiring treatment with oral corticosteroids confirmed by chart review and/or patients assessment by the PI 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.
Exclusion
- Baseline RAVLT total T-Score ≥ 60
- Illnesses associated with CNS involvement (e.g., multiple sclerosis, lupus, seizures, brain tumors, head injury with loss of consciousness of more than 30 minutes) or cognitive impairment (e.g., lifetime drug or alcohol dependence, schizophrenia, and mood disorders - e.g., bipolar disorder, major depressive disorder) that appear to be unrelated to corticosteroid use or history of ventilator use that suggests hypoxia. We will include patients with lupus if they do not appear, based on medical history and discussion with treating physician, have significant CNS involvement. We will include participants with brief loss of consciousness. In prior studies we have found that many otherwise eligible participants were excluded due to very brief LOC in childhood or in a motor vehicle accident.
- Mental retardation or other severe cognitive impairment.
- Pregnant or nursing women.
- Severe or life-threatening medical illness that would make completion of study unlikely or study participation potentially unsafe (e.g., highly unstable asthma requiring frequent hospitalization)
- Contraindications to lamotrigine therapy (severe side effects in the past, taking medications such as some anticonvulsants with drug-drug interactions with lamotrigine).
- High risk or danger to self or others as defined by \> 1 lifetime suicide attempt or assault, any suicide attempt or assault within the past year, and active suicidal or homicidal ideation that includes a plan and intent
- Therapy with medications (valproate, carbamazepine, primidone, phenytoin, rifampin, phenobarbital) that alter the metabolism of lamotrigine
- Metal implants, claustrophobia, or other contraindications to MRI
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01142310
Start Date
June 1 2010
End Date
June 1 2015
Last Update
August 27 2018
Active Locations (1)
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1
Parkland Health and Hospital System (Asthma, Allergy, & Arthritis Clinics)
Dallas, Texas, United States, 75235