Investigating the Effect of Vortioxetine in Adult ADHD Patients

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: Interventional, Randomised, Double-blind, Placebo-controlled, Fixed-dose Study of Vortioxetine in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Status Completed

Clinical Trial Summary

The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult patients with ADHD in a 12 weeks study.

Clinical Trial Description

The study employed the Sequential Parallel Comparison Design (SPCD), a clinical study design which intend to increase signal detection by using two stages of treatment:

• Stage 1 - first 6 weeks of the 12-weeks treatment period (Visit 2/Baseline 1 to Visit 5/Week 6)

• Stage 2 - last 6 weeks of the 12-weeks treatment period (Visit 5/Baseline 2 to Visit 8/Week 12)

In Stage 1, patients were randomized to placebo or vortioxetine 10 or 20mg. Patients on vortioxetine 10 or 20mg/day during Stage 1 remained on the same treatment in Stage 2. Responders to placebo in Stage 1 remained on Placebo in Stage 2. Patients who were placebo non-responders during Stage 1, defined as patients with a <30% reduction in AISRS total score from Baseline 1, were re-randomized to placebo or vortioxetine 10 or 20mg/day in Stage 2. ;

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

• NCT number: NCT02327013
• Study type: Interventional
• Source: H. Lundbeck A/S
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Completion date: September 2016