CompletedNot Applicable

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

Germany63 participantsStarted 2023-09-14

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation.

Exclusion criteria

✕-The following are not excluded: Substance Induced Mood Disorder, Major Depressive Disorder in remission, Generalized Anxiety Disorder in remission, Post-Traumatic Stress Disorder in remission, recreational/occasional substance use as long as willing to stop for duration of the study, Borderline Personality Disorder.

What they're measuring

Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) After Single Dose (at Day 1)

Timeframe: Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.

Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) at Steady State (at Day 14)

Timeframe: Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.

Change From Baseline in Total Score of Short Urgency, Perseverance, Premeditation, and Sensation Seeking-Positive Urgency Impulsive Behavior Scale (S-UPPS-P) Impulsive Behavior Scale After Single Dose (at Day 1)

Timeframe: Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.

Timeframe: Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.

Trial details

NCT IDNCT05278104

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-23

Results submitted2025-10-30

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation.

Exclusion criteria

✕-The following are not excluded: Substance Induced Mood Disorder, Major Depressive Disorder in remission, Generalized Anxiety Disorder in remission, Post-Traumatic Stress Disorder in remission, recreational/occasional substance use as long as willing to stop for duration of the study, Borderline Personality Disorder.

What they're measuring

Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) After Single Dose (at Day 1)

Timeframe: Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.

Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) at Steady State (at Day 14)

Timeframe: Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.

Timeframe: Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.

Timeframe: Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.