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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOQUEST adults | Experimental | adult (≥18 years or older) patients with ADHD receiving FOQUEST (controlled-release methylphenidate 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg, or 100 mg/day) |
|
| VYVANSE adults | Active Comparator | adult (≥18 years or older) patients with ADHD receiving VYVANSE (lisdexamfetamine 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg/day) |
|
| FOQUEST pediatric | Experimental | pediatric (6 to 17 years old) patients with ADHD receiving FOQUEST (controlled-release methylphenidate 25 mg, 35 mg, 45 mg, 55 mg or 70 mg/day) |
|
| VYVANSE pediatric | Active Comparator | pediatric (6 to 17 years old) patients with ADHD receiving VYVANSE (lisdexamfetamine 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate Hydrochloride | Drug | CR Methylphenidate Hydrochloride given once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg or 100 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline ADHD Rating Scale Total Score at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Potential patients who meet any of the contraindications or warnings detailed in the respective Canadian Product Monographs are excluded from participation in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matheson Centre for Mental Health Research & Education, University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada | ||
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Lisdexamfetamine Dimesylate | Drug | Lisdexamfetamine Dimesylate given once daily (10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg) |
|
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| Change from Baseline ADHD Rating Scale Total Score at 4 Months |
| Adult ADHD Centeres at Pacific Coast Recovery Care |
| Burnaby |
| British Columbia |
| V3N 3N4 |
| Canada |
| Medical Arts Health Research Group | Burnaby | British Columbia | V7T 1C5 | Canada |
| The Kids Clinic Inc. | Ajax | Ontario | L1Z 0M1 | Canada |
| Chatham-Kent Clinical Trials Research Centre | Chatham | Ontario | N7L 1C1 | Canada |
| Pediatric Institute of Excellence | Etobicoke | Ontario | M9V 4C2 | Canada |
| Health Sciences North | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Center for Pediatric Excellence | Ottawa | Ontario | K2G1W2 | Canada |
| ADDClinic Windsor | Windsor | Ontario | N8X 4X9 | Canada |
| Recherche Clinique Sigma Inc | Québec | Quebec | G1G 3Y8 | Canada |
| Alpha recherche clinique | Québec | Quebec | G2J 0C4 | Canada |
| Alpha recherche clinique | Québec | Quebec | G3K 2P8 | Canada |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |