Adderall XR and Processing Speed in Multiple Sclerosis (MS)
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Purpose
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? |
- 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
- Change in Score of Stroop Colour Word Test [ Time Frame: pre and 7 hours post dose ] [ Designated as safety issue: No ]Measure of Selective Attention
- Blood Pressure [ Time Frame: 7 hours post dose ] [ Designated as safety issue: Yes ]
- Heart Rate [ Time Frame: 7 hours post dose ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo | Drug: Placebo |
|
Active Comparator: Adderall XR 5mg
treatment group
|
Drug: Adderall XR 5mg |
|
Active Comparator: Adderal XR 10mg
treatment group #2
|
Drug: Adderall XR 10 mg |
Eligibility| 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
- Monoamine Oxidase Inhibitors
- Sympathomimetics or methadone
- Antipsychotic agents
- Modafinil
The following medications are permitted if the dose has been stable for ≥ 28 days
- Short acting benzodiazepines, qhs administration only
- Anticonvulsants, including gabapentin and pregabalin
- Bupropion
- Tricyclic Antidepressants
- Anti-spasmodics such as baclofen or tizanidine
- Anticholinergic medication
- Selective serotonin(-norepinephrine) reuptake inhibitors
Contacts and Locations| Canada, Ontario | |
| London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood) | Not yet recruiting |
| London, Ontario, Canada, N6G 1W8 | |
| Contact: Heather Rosehart, BScH 519 685 8500 ext 34706 heather.rosehart@lhsc.on.ca | |
| Principal Investigator: | Sarah A Morrow, MD, MS, FRCPC | London Health Sciences Center |
More Information
No publications provided
| Responsible Party: | Sarah Morrow, Assistant Professor of Neurology, London Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01667484 History of Changes |
| Other Study ID Numbers: | 102774 |
| Study First Received: | August 13, 2012 |
| Last Updated: | August 16, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by London Health Sciences Centre:
|
Cognitive Impairment Multiple Sclerosis Processing Speed Treatment |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Cognition Disorders Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Adderall Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013