Attenuation of Corticosteroid Induced Hippocampal Changes

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if an investigational drug called memantine,used here as add-on therapy, is associated with improvements in memory, mood and asthma symptoms. We will also examine changes in the brain by taking images or pictures using an MRI/MRS.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Memantine

Criteria

Inclusion Criteria:

• Diagnosis of any chronic medical condition requiring treatment with oral corticosteroids confirmed by chart review and/or patient assessment by Dr. Khan (co-I).

• Receiving prednisone therapy of at least 5 mg of prednisone/day for at least 6 months with anticipated treatment for ≥ 12 additional months.

• Age 18-65 years.

• Baseline CVLT-II total T score ≤ 54.

Exclusion Criteria:

• Illnesses associated with CNS involvement (e.g., seizures, brain tumors, head injury with loss of consciousness) or cognitive impairment (e.g., substance dependence within the past 2 years, bipolar disorder) Potential participants with mood symptoms secondary to corticosteroids (based on SCID) will not be excluded because this could selectively exclude subjects who are sensitive to the CNS effects of corticosteroids.

• Vulnerable populations (e.g. severe cognitive impairment, pregnant or nursing women, prisoners).

• Severe or life-threatening medical illness that would make completion of study unlikely

• Contraindications to memantine therapy (e.g. severe side effects in the past)

• 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 with plan and intent.

• Metal implants, claustrophobia, or other contraindications to MRI