Adderall XR and Processing Speed in Multiple Sclerosis (MS)

This study has been completed.
Information provided by (Responsible Party):
Sarah Morrow, London Health Sciences Centre Identifier:
First received: August 13, 2012
Last updated: May 7, 2015
Last verified: May 2015
Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis (MS) and can occur independently of physical disability. It is the most common reason, along with physical fatigue, for MS patients to stop working. The most frequent complaint is problems with multi-tasking or thinking quickly, which corresponds to impairment in the cognitive domain of processing speed. Currently there is treatment available to prevent relapses and physical disability but there are no medications that have been shown to treat cognitive impairment. Amphetamines have been beneficial for selective attention and processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain injury. This is study will determine whether Adderall XR improves objective measures of processing speed and attention in MS patients impaired in this cognitive domain, by comparing two doses of Adderall XR (5 and 10mg) to placebo before and after the medication is administered. The results of this study will help provide data to design a larger study to determine if Adderall XR, and potentially other amphetamine drugs, will help treat cognitive impairment in MS patients.

Condition Intervention Phase
Impaired Processing Speed
Cognitive Impairment
Multiple Sclerosis
Drug: Adderall XR 5mg
Drug: Adderall XR 10 mg
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?

Resource links provided by NLM:

Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • Change in score of Paced Auditory Serial Addition Test (PASAT) [ Time Frame: pre and 7 hours post dose ] [ Designated as safety issue: No ]
    measure of processing speed

  • Change in Score of Symbol Digit Modalities Test (SDMT) [ Time Frame: pre and 7 hours post dose ] [ Designated as safety issue: No ]
    measure of processing speed

Enrollment: 70
Study Start Date: September 2012
Study Completion Date: February 2015
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
treatment group #1
Drug: Placebo
Active Comparator: Adderall XR 5mg
treatment group #2
Drug: Adderall XR 5mg
Active Comparator: Adderal XR 10mg
treatment group #3
Drug: Adderall XR 10 mg


Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • - Males/Females who are ≥ 18 years old and ≤ 59 years old
  • Relapsing Remitting, Secondary Progressive or Primary Progressive MS, as per revised McDonald's Criteria
  • Have not received corticosteroids in last thirty days or a relapse in the last ninety days
  • An Expanded Disability Status Scale (EDSS) of ≤ 6.5
  • If female, must neither be pregnant nor breast-feeding

Exclusion Criteria:

  • - Have evidence of other medical cause(s) of cognitive impairment
  • Have evidence of major depression as determined by a positive Beck Depression Index-Fast screen ≥ 13and/or by clinician interview or evidence of severe fatigue with a Fatigue Severity Scale ≥ 5.
  • Have demonstrated a hypersensitivity to amphetamines in the past
  • Have uncontrolled or labile hypertension (> 135/85 mm Hg, treated or untreated)
  • Have a history of structural heart disease, including atherosclerosis or angina
  • Have a diagnosis of bipolar disorder or a history of a psychotic episode
  • The following medications are not permitted to be used within 14 days the study

    1. Monoamine Oxidase Inhibitors
    2. Sympathomimetics or methadone
    3. Antipsychotic agents
    4. Modafinil
  • The following medications are permitted if the dose has been stable for ≥ 28 days

    1. Short acting benzodiazepines, qhs administration only
    2. Anticonvulsants, including gabapentin and pregabalin
    3. Bupropion
    4. Tricyclic Antidepressants
    5. Anti-spasmodics such as baclofen or tizanidine
    6. Anticholinergic medication
    7. Selective serotonin(-norepinephrine) reuptake inhibitors
  Contacts and Locations
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Please refer to this study by its identifier: NCT01667484

Canada, Ontario
London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)
London, Ontario, Canada, N6G 1W8
Sponsors and Collaborators
London Health Sciences Centre
Principal Investigator: Sarah A Morrow, MD, MS, FRCPC London Health Sciences Center
  More Information

Responsible Party: Sarah Morrow, Assistant Professor of Neurology, London Health Sciences Centre Identifier: NCT01667484     History of Changes
Other Study ID Numbers: 102774 
Study First Received: August 13, 2012
Last Updated: May 7, 2015
Health Authority: Canada: Health Canada

Keywords provided by London Health Sciences Centre:
Cognitive Impairment
Multiple Sclerosis
Processing Speed

Additional relevant MeSH terms:
Cognition Disorders
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Pathologic Processes
Central Nervous System Stimulants
Physiological Effects of Drugs processed this record on May 25, 2016