Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280774
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2006-01-19
Brief Title:
Memantine for Corticosteroid-Induced Mood and Declarative Memory Changes
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Memantine for Corticosteroid-Induced Mood and Declarative Memory Changes A Pilot Study
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 manichypomanic symptoms feelings of agitation overexcitement or hyperactivity andor 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 mgday 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
Detailed Description:
Twenty 20 outpatients with pulmonary eg asthma rheumatic eg 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 mgday 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 mgday 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
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 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NAM-MD-26 | None | None | None |