Memantine or Riluzole Prophylaxis for Corticosteroid-induced Mood and Declarative Memory Changes
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| ClinicalTrials.gov Identifier: NCT00283309 |
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Recruitment Status :
Terminated
(Study finished enrollment but data was never sent for publishing.)
First Posted : January 27, 2006
Last Update Posted : April 23, 2013
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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 manic/hypomanic symptom severity than those receiving placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mood Memory Deficit | Drug: Memantine Drug: Riluzole | Phase 4 |
Twenty five (25) outpatients with pulmonary (e.g. asthma, cystic fibrosis) or rheumatic (e.g. 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Study Start Date : | November 2005 |
| Actual Primary Completion Date : | April 2007 |
| Actual Study Completion Date : | April 2007 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Memantine
Memantine is used to determine if patients given pretreatment to corticosteroid therapy for inflammatory illnesses will show lesser declarative memory impairment than those receiving placebo. Baseline 10mg x 3 days, then 10mg BID x 4 days.
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Drug: Memantine |
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Placebo Comparator: Placebo
Inactive ingredient matching the active medication in appearance
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Drug: Memantine Drug: Riluzole |
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Active Comparator: Riluzole
Riluzole is given to patients receiving corticosteroid therapy for inflammatory illnesses pretreatment to determine if they show lesser declarative memory impairment than those receiving placebo. Baseline 50mg x 3 days, then 50mg BID x 4 days.
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Drug: Riluzole |
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18-70 years old
- English speaking
- Able to provide informed consent
- Scheduled to receive a corticosteroid burst of at least 20 mg prednisone or equivalent for at least 7 days
Exclusion Criteria:
- History of allergic reaction to memantine and/or riluzole
- Pregnant or nursing women
- History of liver disease, myocardial infarction, renal failure, diabetes with poor glycemic control, or other unstable medical condition
- Mental retardation, dementia, or other severe cognitive disorder
- Prior prednisone therapy in the last 14 days
- Current alcohol/substance abuse/dependence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283309
| United States, Texas | |
| UT Southwestern | |
| Dallas, Texas, United States, 75390 | |
| Principal Investigator: | Sherwood Brown | University of Texas, Southwestern Medical Center at Dallas |
Additional Information:
| Responsible Party: | Sherwood Brown, Principal Investigator, MD/PhD, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00283309 History of Changes |
| Other Study ID Numbers: |
042005-018 |
| First Posted: | January 27, 2006 Key Record Dates |
| Last Update Posted: | April 23, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Sherwood Brown, University of Texas Southwestern Medical Center:
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Corticosteroids Riluzole Memantine Memory |
Additional relevant MeSH terms:
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Memory Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Memantine Riluzole Antiparkinson Agents Anti-Dyskinesia Agents |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Anticonvulsants Neuroprotective Agents Protective Agents |