Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01142310 : Reversing Corticosteroid Induced Memory Impairment
PhasePhase 4
AgesMin: 18 Years Max: 70 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01142310      |      Link to official Clinicaltrials.gov listing
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