PatientsVille.com LogoPatientsVille.com

Impaired Processing Speed | Adderall XR and Processing Speed in Multiple Sclerosis (MS)

Impaired Processing Speed research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Impaired Processing Speed

Cognitive Impairment

Multiple Sclerosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Adderall XR 5mg

Drug:Adderall XR 10 mg

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Placebotreatment group #1

Adderall XR 5mgtreatment group #2

Adderal XR 10mgtreatment group #3

Study Status

Completed

Start Date: September 2012

Completed Date: February 2015

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Change in score of Paced Auditory Serial Addition Test (PASAT)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Sarah A Morrow, MD, MS, FRCPC

Lead Sponsor: London Health Sciences Centre

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01667484

Discuss Adderall