Memantine for Corticosteroid-Induced Mood and Declarative Memory Changes

Completed · Phase 4

Conditions studied: Physiological Effects of Drugs

In brief

The purpose of this research is to determine if patients on corticosteroids who are given memantine will show improvement in memory compared to those receiving placebo (an inactive substance). This research also seeks to determine if such patients, when given memantine, will experience improvement in manic/hypomanic symptoms (feelings of agitation, overexcitement, or hyperactivity) and/or depressive symptoms. Subjects will be randomized to a crossover trial of memantine and placebo for 8 weeks, followed by a 4 week washout and then 8 more weeks of the study medication. Memantine and placebo will start at 5 mg/day for one week, increased to 5 mg twice a day in the second week. During the third week patients will take 10 mg in the morning and 5 mg in the evening. At weeks 4-8, patients will take 10 mg twice a day. One 8 week course of study medication will be memantine and the other 8 week course of study medication will be placebo, both assigned in a random fashion.

Key facts

Study ID

NCT00280774

Run by

University of Texas Southwestern Medical Center

People needed

20

Starts

2006-03-01

Expected to finish

2007-02-01

Last updated by the study team

2008-01-25

Who can join

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

You may qualify if…

• Patients between (and including) ages 18-70 and taking at least 5 mg/day of prednisone equivalents for at least 3 months and anticipating continued treatment at the same dose for at least 20 additional weeks will be eligible for enrollment.

You may not qualify if…

• Patients with a history of allergic reaction or other contraindication to memantine therapy or with other unstable medical conditions (e.g. recent myocardial infarction, diabetes with poor glycemic control) will not be allowed to participate.
• Pregnant or nursing women or women of childbearing age who will not use University of Texas Southwestern (UTSW) Institutional Review Board (IRB) approved methods of avoiding pregnancy will be excluded from the study.
• Those with a history of mental retardation, dementia, or other severe cognitive disorders will also be excluded from the study.
• Patients with baseline RAVLT total words recalled normative score > 55 will be excluded to avoid including persons with exceptionally good declarative memory at baseline.
• Subjects who do not speak English will be excluded because many of the outcome measures used in this study are not validated in languages other than English.

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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