Recall Enhancement Through Treatment With Atomoxetine in MS (RETAIN-MS)
Condition: Memory Disorders; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Memory Disorders; Sclerosis
Intervention: Atomoxetine; Placebo
Intervention description: Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks); Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Memory Disorders; Multiple Sclerosis; Atomoxetine Hydrochloride

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.
    

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:

               1. 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.