Trial intelligence / Profile preview

Vortioxetine in Adults With ADHD

NCT02327013Phase 2

Key facts

Status: Completed
Start: Dec 2014
Primary completion: Sep 2016
Countries: 1
Sponsor: Lundbeck
Modality: Small Molecules

Drugs: vortioxetine
Conditions: attention deficit hyperactivity disorder (ADHD)

Overview

Phase 2, randomised, double-blind trial of vortioxetine in attention deficit hyperactivity disorder (ADHD) (3 arms), sponsored by Lundbeck. Primary endpoint: Change in ADHD Investigator Symptom Rating Scale Total Score at 6 weeks. Started Dec 2014; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

vortioxetine 10 mg tablet
Vortioxetine 10 mg/day
vortioxetine 20 mg tablet
Vortioxetine 20 mg/day
Placebo tablet
Placebo

Who it enrols

Adult outpatients (18-55 years) with a primary diagnosis of ADHD (DSM-5), AISRS total score >= 24, and CGI-S >= 4. Excludes patients with other current psychiatric disorders, history of bipolar disorder in first-degree relatives, intellectual disability, organic mental disorders, substance abuse, or history of two prior failed adequate trials of ADHD treatment.

Endpoints

Primary

Change in ADHD Investigator Symptom Rating Scale Total Score6 weeks

Secondary

Change in Behavior Rating Inventory of Executive Function - Adult Version Metacognition Index6 weeks
Change in BRIEF-A Global Executive Composite Score6 weeks
Change in Sheehan Disability Scale Total Score6 weeks
Change in Work Limitations Questionnaire Productivity Loss Score6 weeks
Change in AISRS Inattention Sub-score6 weeks
Change in AISRS Hyperactivity/Impulsivity Sub-score6 weeks
Percentage of Patients Responding (>=30% Reduction in AISRS Total Score)6 weeks
Change in Adult ADHD Self-Report Scale Total Score6 weeks

Results

Not all primary endpoints met

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