Reversing Corticosteroid Induced Memory Impairment
Condition: Memory Impairment
MeSH terms: Memory Disorders
Intervention: Lamotrigine; Placebo
Intervention description: Lamotrigine will be initiated at 25 mg/day and upwardly titrated to a dose of 400 mg/day over 10 weeks.
Intervention MeSH terms: Lamotrigine
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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