A Study to Test Different Ways to Measure the Effect of Atomoxetine on Impulsive Behavior in Young Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Zentiva®; Drug: Placebo

• Registration Number: NCT05278104
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objectives are to investigate the effect of atomoxetine on impulsivity after single dose and at steady state measured by the total score of Barrett Impulsiveness Scale version 11 (BIS-11) and Short Urgency, Perseverance, Premeditation, and Sensation Seeking-Positive Urgency Impulsive Behavior Scale (S-UPPS-P) Impulsive Behavior Scale. The secondary objective is to evaluate the safety of atomoxetine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-14
• Study Start: 2023-09-14
• Primary Completion: 2024-10-23
• Study Completion: 2024-10-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atomoxetine	Zentiva®	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in total score of Barratt Impulsiveness Questionnaire version 11 (BIS-11) after single dose	at day 1	The total BIS-11 score ranges from 30 to 120 with a higher score indicating an increased impulsive behavior.
Change from baseline in total score of Barratt Impulsiveness Questionnaire BIS-11 at steady state	at day 14	The total BIS-11 score ranges from 30 to 120 with a higher score indicating an increased impulsive behavior.
Change from baseline in total score of S-UPPS-P Impulsive Behavior Scale after single dose	at day 1	S-UPPS-P = Short Urgency, Perseverance, Premeditation, and Sensation Seeking, Positive Urgency Impulsive Behavior Scale; The S-UPPS-P Impulsive Behavior Scale ranges from 20 to 80 with a higher score indicating an increased impulsive behavior.
Change from baseline in total score of S-UPPS-P Impulsive Behavior Scale at steady state	at day 14	S-UPPS-P = Short Urgency, Perseverance, Premeditation, and Sensation Seeking, Positive Urgency Impulsive Behavior Scale; The S-UPPS-P Impulsive Behavior Scale ranges from 20 to 80 with a higher score indicating an increased impulsive behavior.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with (serious) adverse events.	up to 28 days

Trial Locations

Locations (5)

Universitätsklinikum Aachen, AöR; 🇩🇪 Aachen, Germany

Rheinhessen-Fachklinik Alzey; 🇩🇪 Alzey, Germany

Universitätsklinikum Bonn AöR; 🇩🇪 Bonn, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany