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Interventional, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of Vortioxetine in Adults with Attention Deficit Hyperactivity Disorder (ADHD)

Principal Investigator:
Robert
Findling

Primary Objective:

To evaluate the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on ADHD symptoms in the treatment of adult patients with a DSM-5™ diagnosis of ADHD.

Secondary Objectives:

  • To evaluate the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on:
    • Inattention (patient-reported outcome [PRO])
    • Overall functioning (PRO)
    • Emotional dysregulation (PRO)
    • ADHD symptoms (investigator-rated)
    • ADHD symptoms (PRO)
    • Cognitive function (PRO)
    • Global clinical impression (investigator-rated)
    • Productivity (PRO)
    • Health-related quality of life (PRO)

Additional Objectives:

  • To evaluate the population pharmacokinetics of vortioxetine in adult patients with ADHD and estimate individual oral clearance (CL/F) values
  • To evaluate the compliance with vortioxetine treatment for the individual patient based on the plasma concentrations and the estimated CL/F
  • To investigate associations between biomarkers and clinical features

Safety Objective:

To evaluate the safety and tolerability of vortioxetine 10 mg/day and 20 mg/day versus placebo in adult patients with a diagnosis of ADHD.

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