Reversing Corticosteroid Induced Memory Impairment

Completed · Phase 4 · Has a placebo group

Conditions studied: Memory Impairment

In brief

Medically stable outpatients receiving chronic oral corticosteroid therapy were enrolled in a 48-week randomized, double-blind, placebo-controlled, parallel-group, trial of lamotrigine.

Key facts

Study ID

NCT01142310

Run by

University of Texas Southwestern Medical Center

People needed

54

Starts

2010-06-01

Expected to finish

2015-06-01

Last updated by the study team

2018-08-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Parkland Health and Hospital System (Asthma, Allergy, & Arthritis Clinics) — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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