This study is a four-month, phase IV, open-label study of ADHD symptomatology and functional outcomes in pediatric (6 to 17 years old) and adult (≥18 years or older) patients with ADHD treated with FOQUEST or VYVANSE.
After giving written, informed consent or assent (for patients \<18 years old), patients will be screened to ascertain their suitability for the study according to the patient selection criteria (Section 4). Based on clinician assessment, patients will be assigned to receive either FOQUEST or VYVANSE. Patients will be titrated to their optimal dose of ADHD medication based on Investigator judgement. At monthly visits, patients will have their ADHD symptomatology evaluated by the Investigator (ADHD-Rating Scale-DSM 5 Version \[ADHD-RS-5\]) and will complete questionnaires on functional outcomes (Weiss Functional Impairment Ratings Scale - Parent \[WFIRS-P\] or Weiss Functional Impairment Ratings Scale - Self \[WFIRS-Self\]), morning and evening behaviours (Daily Parent Rating of Evening and Morning Behaviours - Revised \[DPREMB-R\] or Adult ADHD Quality of Life Rating Scale - Revised \[AAQoL-R\]) and Patient Sleep \& Satisfaction survey (PSS). Safety will be evaluated through non-directed spontaneous adverse event (AE) reporting. Patients will be monitored for signs of suicide-related behavior, as per standard of care. A post-study safety follow-up phone call (conducted between 7 and 14 days post-last visit) will assess patients for any adverse events that occur following their last dose of medication received as part of the study. Following the last dose of study medication, the patient's continuing, post-study ADHD treatment will be based on Investigator discretion and standard of care.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
257
CR Methylphenidate Hydrochloride given once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg or 100 mg)
Lisdexamfetamine Dimesylate given once daily (10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg)
Matheson Centre for Mental Health Research & Education, University of Calgary
Calgary, Alberta, Canada
Adult ADHD Centeres at Pacific Coast Recovery Care
Burnaby, British Columbia, Canada
Medical Arts Health Research Group
Burnaby, British Columbia, Canada
Change in ADHD Rating Scale Total Score
The ADHD Rating Scale DSM-5 (ADHD-RS-5) is a clinician-rated scale that reflects current symptoms of ADHD based on DSM-5 criteria. It is a global assessment that measures the severity of symptoms from visit to visit, but is not utilized to assess symptoms of ADHD over the course of the day. The ADHD-RS-5 consists of 18 items that are grouped into two subscales (hyperactivity/impulsivity, and inattention). Higher score means higher frequency and severity of symptoms.
Time frame: Change from Baseline ADHD Rating Scale Total Score at 4 months
Non-Inferiority Comparison between Treatments in Change in ADHD Rating Scale Total Score
The ADHD Rating Scale DSM-5 (ADHD-RS-5) is a clinician-rated scale that reflects current symptoms of ADHD based on DSM-5 criteria. It is a global assessment that measures the severity of symptoms from visit to visit, but is not utilized to assess symptoms of ADHD over the course of the day. The ADHD-RS-5 consists of 18 items that are grouped into two subscales (hyperactivity/impulsivity, and inattention). Higher score means higher frequency and severity of symptoms.
Time frame: Change from Baseline ADHD Rating Scale Total Score at 4 Months
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The Kids Clinic Inc.
Ajax, Ontario, Canada
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, Canada
Pediatric Institute of Excellence
Etobicoke, Ontario, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
Center for Pediatric Excellence
Ottawa, Ontario, Canada
ADDClinic Windsor
Windsor, Ontario, Canada
Recherche Clinique Sigma Inc
Québec, Quebec, Canada
...and 2 more locations