Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283309
Status:
TERMINATED
Last Update Posted:
2013-04-23
First Post:
2006-01-24
Brief Title:
Memantine or Riluzole Prophylaxis 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:
None
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study finished enrollment but data was never sent for publishing
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose is to determine if patients scheduled to receive prescription corticosteroid therapy for inflammatory illnesses who are given either memantine or riluzole pretreatment will show lesser declarative memory impairment than those receiving placebo
The exploratory purpose is to determine if patients scheduled to receive prescription corticosteroid therapy for inflammatory illnesses who are given memantine or riluzole pretreatment will show a smaller increase in manichypomanic symptom severity than those receiving placebo
The exploratory purpose is to determine if patients scheduled to receive prescription corticosteroid therapy for inflammatory illnesses who are given memantine or riluzole pretreatment will show a smaller increase in manichypomanic symptom severity than those receiving placebo
Detailed Description:
Twenty five 25 outpatients with pulmonary eg asthma cystic fibrosis or rheumatic eg rheumatoid arthritis dermatomyositis illnesses scheduled to receive a brief course burst of prednisone will be enrolled The subjects will be randomized to receive memantine riluzole or placebo beginning immediately prior to the corticosteroid therapy and continuing for one week Measures of cognition and mood will be compared between the two groups at baseline day 3 and day 7
Demographic information including age gender frequency and duration of prior corticosteroid therapy and current anticipated dose and duration will be collected at baseline 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 RAVLT primary measure Stroop and Digit Span Backwards The subjects will be given memantine 10 mg riluzole 50 mg or identical appearing placebo 1 tablet daily for 3 days and then at the first follow up appointment day 3 the dose will be increased to BID if no side effects are reported The subjects will be reassessed twice at day 3 and day 7 Mood and cognitive measures will be repeated The study visits will last approximately an hour and a half Participants will discontinue memantine when they discontinue prednisone The RA administering assessments will be blinded at all times Alternative but equivalent versions of the RAVLT and Digit Span Backwards 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
HVLT-R test total words recalled scores will be compared between baseline and exit of the active medication phase and placebo phase using a within subjects design and paired t-tests Based on our prior experience working with corticosteroid-dependent patients we have found them to be very compliant with clinical treatment Thus we do not anticipate large numbers of dropouts or missing data 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 total words recalled on a word list and on the Stroop Assuming a similar change with memantine 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 up to 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
Demographic information including age gender frequency and duration of prior corticosteroid therapy and current anticipated dose and duration will be collected at baseline 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 RAVLT primary measure Stroop and Digit Span Backwards The subjects will be given memantine 10 mg riluzole 50 mg or identical appearing placebo 1 tablet daily for 3 days and then at the first follow up appointment day 3 the dose will be increased to BID if no side effects are reported The subjects will be reassessed twice at day 3 and day 7 Mood and cognitive measures will be repeated The study visits will last approximately an hour and a half Participants will discontinue memantine when they discontinue prednisone The RA administering assessments will be blinded at all times Alternative but equivalent versions of the RAVLT and Digit Span Backwards 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
HVLT-R test total words recalled scores will be compared between baseline and exit of the active medication phase and placebo phase using a within subjects design and paired t-tests Based on our prior experience working with corticosteroid-dependent patients we have found them to be very compliant with clinical treatment Thus we do not anticipate large numbers of dropouts or missing data 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 total words recalled on a word list and on the Stroop Assuming a similar change with memantine 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 up to 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