Adderall XR and Processing Speed in Multiple Sclerosis (MS)

Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Cognitive Impairment; Impaired Processing Speed
• Intervention / Treatment: Drug: Placebo; Drug: Adderall XR 5mg; Drug: Adderall XR 10 mg

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 1W8
      • London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score of Paced Auditory Serial Addition Test (PASAT)	measure of processing speed	pre and 7 hours post dose
Change in Score of Symbol Digit Modalities Test (SDMT)	measure of processing speed	pre and 7 hours post dose

Collaborators and Investigators

• Sponsor: London Health Sciences Centre
• Investigators: Principal Investigator: Sarah A Morrow, MD, MS, FRCPC, London Health Sciences Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: August 13, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 7, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Treatment; Cognitive Impairment; Processing Speed
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurocognitive Disorders; Cognition Disorders; Multiple Sclerosis; Sclerosis; Cognitive Dysfunction; Physiological Effects of Drugs; Central Nervous System Stimulants; Adderall
• Other Study ID Numbers: 102774