Phase 4
Completed N=46
Attenuation of Corticosteroid Induced Hippocampal Changes
Organic Memory Impairment
Source: ClinicalTrials.gov NCT01656187 ↗
Enrolled (actual)
46
Serious AEs
20.7%
Results posted
Mar 2019
Primary outcomePrimary: Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score — 39.40; 36.93; 37.67; 38.37 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to determine if an investigational drug called memantine,used here as add-on therapy, is associated with improvements in memory, mood and asthma symptoms. We will also examine changes in the brain by taking images or pictures using an MRI/MRS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score |
39.40; 36.93; 37.67; 38.37 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of any chronic medical condition requiring treatment with oral corticosteroids confirmed by chart review and/or patient assessment by Dr. Khan (co-I).
- Receiving prednisone therapy of at least 5 mg of prednisone/day for at least 6 months with anticipated treatment for ≥ 12 additional months.
- Age 18-65 years.
- Baseline CVLT-II total T score ≤ 54.
Exclusion Criteria
- Illnesses associated with CNS involvement (e.g., seizures, brain tumors, head injury with loss of consciousness) or cognitive impairment (e.g., substance dependence within the past 2 years, bipolar disorder) Potential participants with mood symptoms secondary to corticosteroids (based on SCID) will not be excluded because this could selectively exclude subjects who are sensitive to the CNS effects of corticosteroids.
- Vulnerable populations (e.g. severe cognitive impairment, pregnant or nursing women, prisoners).
- Severe or life-threatening medical illness that would make completion of study unlikely
- Contraindications to memantine therapy (e.g. severe side effects in the past)
- Danger to self or others as defined by > 1 lifetime suicide attempt or assault, any suicide attempt or assault within the past year, and active suicidal or homicidal ideation with plan and intent.
- Metal implants, claustrophobia, or other contraindications to MRI
Data sourced from ClinicalTrials.gov (NCT01656187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.