Phase 2
Completed N=11
Recall Enhancement Through Treatment With Atomoxetine in MS (RETAIN-MS)
Memory Disorders · Multiple Sclerosis
Source: ClinicalTrials.gov NCT03091400 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Change in Memory Change — 0.32; 0.24 z-score
Summary
The purpose of this crossover trial is to investigate whether atomoxetine (versus placebo) improves memory function in persons with memory deficits due to multiple sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Memory Change |
0.32; 0.24 | — |
| SECONDARY Change in Patient-Reported Memory Change |
0.70; 0.90 | — |
| SECONDARY Change in CANTAB Paired Associate Learning |
-10.30; -8.10 | — |
| SECONDARY Change in NIH Toolbox Picture Sequence Memory Test |
4.50; 3.20 | — |
| SECONDARY Change in Perceived Deficits Questionnaire (PDQ) |
-6.60; -5.90 | — |
| SECONDARY Change in Symbol Digit Modalities Test |
7.20; 5.50 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Multiple Sclerosis based on the Revised McDonald criteria
- Age 21 - 60 years.
- Patient self-report of memory decline from previously higher level of functioning.
- Memory Impairment on validated neuropsychological memory screening tests, as follows:
- performance ≤16th percentile on both (i) Rey Auditory Verbal Learning Test (RAVLT) Total Learning (TL) and (ii) WMS-IV Visual Reproduction I (VR-I); and b) mean normative memory performance (RAVLT TL and WMS-IV VR-I) is at least 1.0 standard deviation below expectations based on the Wechsler Test of Adult Reading (WTAR)
Exclusion Criteria
- Current stimulant medication usage.
- Previous diagnosis or treatment for ADHD or any neurologic condition other than multiple sclerosis (e.g., traumatic brain injury, epilepsy)
- Clinical relapse of MS within 60 days of screening,
- Change in disease-modifying therapy within 90 days of screening,
- Below average estimated premorbid intelligence (WTAR, < 16th percentile),
- Severe cognitive impairment indicated by a Mini-Mental Status Examination (MMSE) < 24/30.
- Contraindications for atomoxetine use: (a) self-reported history of suicidal ideation within the last twelve months (Columbia Suicide Severity Rating Scale), (b) diagnosis of bipolar illness, (c) moderate or severe current depressive symptomatology (Beck Depression Inventory Fast Screen ≥ 9), (d) diagnosis of hepatic disease, (e) narrow angle glaucoma, (f) pheochromocytoma, (g) monoamine oxidase inhibitor within 14 days of study drug start, (h) taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine), (i) diagnosis of heart disease, (j) pregnant or planning pregnancy during the study period, (k) breastfeeding, (l) hypersensitivity to atomoxetine or component of formulation.
Data sourced from ClinicalTrials.gov (NCT03091400). 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.