An open-label pragmatic study to assess the real-world effectiveness of Adhansia XRTM in treatment of adult and adolescent patients with ADHD in the United States

About this Study

To assess the real-world (RW) effectiveness of Adhansia XR among adolescent and adult patients diagnosed with ADHD, by comparing the total score results of the ADHD-Rating Scale 5 (ADHD-RS-5) at Month-2 to the baseline visit among patients receiving Adhansia XR

Sponsor Protocol ID:ADA4003
IRB Number:2020V0169
Closed for Enrollment
Interventional
Phase 4
Eligibility Criteria
12 years old
Both Male and Female
No
No
No

Inclusion Criteria1.  Patient with a physician-confirmed diagnosis of ADHD

2. Patient must be 12 years of age or older

3. Patient must be an appropriate patient to receive Adhansia XR or OROS MPH (or Concerta) according to the US product labels

4. Patient must be willing to take only the assigned study medication per HCP instructions based on FDA label guidance for treatment of their ADHD for the first 2 months of the study

Exclusion Criteria1. Concurrent participation in an investigational study in which patient assessment and/or treatment may be dictated by a protocol

2.  Patient is adequately treated for ADHD on current treatment

3.  Female patients of child bearing potential who are pregnant, planning on becoming pregnant or breastfeeding

4. Patients with a known sensitivity to the food dye tartrazine

5. Suicidal Ideation

6. Inability or unwillingness of the patient (or parent/guardian if patient is a minor) to complete the study-required electronic questionnaires and provide required information through electronic means

Categories Click category to view its trials.
Behavioral Health/Psychology
Pediatrics
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Jamie Brown
Phone Number: 601-496-7810
Email: jlbrown@umc.edu
Principal Investigator:Sarver, Dustin E, Ph.D.
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