Physiological Effects of Drugs Clinical Trial
Official title:
Memantine for Corticosteroid-Induced Mood and Declarative Memory Changes: A Pilot Study
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.
Twenty (20) outpatients with pulmonary (e.g. asthma), rheumatic (e.g. rheumatoid arthritis,
dermatomyositis) illnesses or renal transplants (all populations we have used in prior
clinical trials) receiving a course of prednisone or other corticosteroid for at least 12
weeks will be enrolled. To participate, patients must be between the ages of 18 and 70 and
taking at least 5 mg/day of prednisone, or a prednisone equivalent, for at least 3 months
and with the expectation that they will be continuing such treatment at the same dose for at
least 20 additional weeks. At baseline, the research assistant or study doctor will ask
patients about their health, any prior corticosteroid therapy and other medications patients
may take for any health problems, medication allergies, and any surgical procedures or
cognitive impairments they may have. Patients will have memory tests and answer questions
about their mood, sleep, appetite, and daily activities.
The 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 study drug. Memantine will be started
at 5 mg/day for 1 week, increased to 5 mg BID in the second week, 10 mg QAM and 5 mg QHS the
next week and to 10 mg BID in weeks 4-8 as directed in the package insert. One 8 week course
will be memantine and the other placebo assigned in a random fashion. Measures of memory
will be compared within subjects at baseline, week 4, week 8, week 12 (beginning of second
course of study drug), week 16 and week 20 (exit). At weeks 2 and 14, participants will be
given 3 questionnaires that will measure mood; medication management will be conducted
during these assessments. Each visit, including baseline, should take approximately one and
a half hours.
Detailed Experimental: Baseline measures of mood will be assessed with the Activation
subscale of the Internal State Scale (ISS) (primary measure), Hamilton Depression Rating
Scale (17-item version), and Young Mania Rating Scale (YMRS). Cognition will be assessed
with the HVLT-R (primary measure), and STROOP color word task. The subjects will be given
memantine or identical appearing placebo as described above. Reductions in dosage will be
allowed should clinically significant side effects emerge based on the judgment of a blinded
psychiatrist. The above cognitive measures will be administered at each assessment visit (8
total); during the assessments at week 2 and week 14 patients will also be given 3 mood
questionnaires. Each visit will be approximately an hour and half in length. The RA doing
assessments will be blinded at all times. Alternative but equivalent versions of the HVLT-R
will be given to minimize practice or learning effects. Current and cumulative
corticosteroid dose (mg each day X number of days) will be determined and recorded.
In the case of missing data we will use the last observation carried forward. In our
lamotrigine study in a similar population, we found a change in the total words recalled on
a word list and on the Stroop. Assuming a similar change with memantine and using
double-sided, paired t-tests, we could detect a difference with a change in the placebo
group with participants on the HVLT-R and with participants on the STROOP. Thus, although
this is primarily a pilot study to obtain effect sizes for future, larger trials funded by
NIH, it should have power to detect clinically meaningful differences between medication and
placebo.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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