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

Double-blind, Randomized, Parallel Group, Placebo Controlled Clinical Trial to Evaluate the Effects of Atomoxetine on Impulsivity in Behavioral Laboratory Tasks in Adult ADHD Patients

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Zentiva®; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen, AöR
  • Alzey, Germany, 55232
    • Rheinhessen-Fachklinik Alzey
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn AöR
  • Frankfurt, Germany, 60528
    • Universitätsklinikum Frankfurt
  • Leipzig, Germany, 04103
    • Universitatsklinikum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• Male and female subjects, 18-45 years of age at the time of consent meeting diagnostic criteria of Attention Deficit Hyperactivity Disorder (ADHD) per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) at screening visit and currently undergoing diagnostic assessment and/or treatment for ADHD
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
• A diagnosis of the moderate symptoms of ADHD confirmed with combined score of 4 or higher in Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) at Screening; Hyperactivity/Impulsivity subscale min 8 (at least moderate for impulsivity measure with ADHD checklist)
• Able and willing to discontinue the use of any psychotropic medications for treatment of ADHD symptoms, as well as of all relevant co-medication for comorbid conditions during the study

• Women of childbearing potential (WOCBP) [1] must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the patient information.

  1. 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

• Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder or major depressive disorder (MDD) with psychotic features at the time of screening.

• Diagnosis of any mental disorder (according to DSM-5) that was primary focus of treatment within 6 months prior to Screening or at Baseline (as per clinical discretion of the investigator).

  --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.

• Any psychiatric disorder, including the ones mentioned under #1, that in the opinion of the investigator would compromise participants' safety and/or validity of the data.
• Current or recent (in the 6 months prior to screening) suicidal ideation or behaviour of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS).
• Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), temperature, or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator.
• Repeated measurement of systolic blood pressure outside the range of 90 to 145 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 45 to 95 beats per minute (bpm).
• A marked baseline prolongation of QT/QTc interval ([QT/QTc = Time between start of the Q-wave and the end of the T-wave in an electrocardiogram / QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB)] such as QTc intervals that are repeatedly greater than 450 milliseconds (ms) in males or repeatedly greater than 470 ms in females) or any other relevant electrocardiogram (ECG) finding at screening.
• A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome).
• Further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atomoxetine; Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of Atomoxetine consisting of one 40 mg capsule in the morning at home. Day 9 to Day 14: Participants took a single dose of Atomoxetine consisting of two 40 mg capsules (totaling 80 mg) in the morning at home.	Drug: Zentiva®; Zentiva®, oral, tablet; Other Names: Atomoxetin
Placebo Comparator: Placebo (matching Atomoxetine); Day 1 and Day 8: After fasting for at least 10 hours overnight, participants received a single dose of placebo (matching Atomoxetine) in the morning at the trial site. Day 2 to Day 7: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home. Day 9 to Day 14: Participants took a single dose of placebo (matching Atomoxetine) in the morning at home.	Drug: Placebo; Placebo, oral, tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) After Single Dose (at Day 1)	The BIS-11 evaluates impulsiveness via 30 items scored on a 4-point scale (Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4). Total scores range from 30 (least impulsive) to 120 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness. The data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving <90% of planned doses), their data were included in the analysis only up to the point of discontinuation. Reported summary data was based on an ANCOVA with the BIS-11 score at baseline as a covariate and the treatment arm as fixed factor.	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)	The BIS-11 evaluates impulsiveness via 30 items scored on a 4-point scale (Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4). Total scores range from 30 (least impulsive) to 120 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness. The data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving <90% of planned doses), their data were included in the analysis only up to the point of discontinuation. Reported summary data was based on an ANCOVA with the BIS-11 score at baseline as a covariate and the treatment arm as fixed factor.	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)	The S-UPPS-P assesses impulsivity across five traits using 20 items scored on a 4-point scale (Agree Strongly = 1; Agree Some = 2; Disagree Some = 3; Disagree Strongly = 4). Total scores range from 20 (least impulsive) to 80 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness. The data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving <90% of planned doses), their data were included in the analysis only up to the point of discontinuation. Reported summary data was based on an ANCOVA with the S-UPPS-P score at baseline as a covariate and the treatment arm as fixed factor.	Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.
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 at Steady State (at Day 14)	The S-UPPS-P assesses impulsivity across five traits using 20 items scored on a 4-point scale (Agree Strongly = 1; Agree Some = 2; Disagree Some = 3; Disagree Strongly = 4). Total scores range from 20 (least impulsive) to 80 (most impulsive), calculated by summing item scores. Higher scores indicate greater impulsiveness. The data used in the analysis of covariance (ANCOVA) were estimated regardless of whether participants used rescue or other concomitant medications, or experienced nausea/vomiting. For participants who discontinued treatment early (receiving <90% of planned doses), their data were included in the analysis only up to the point of discontinuation. Reported summary data was based on an ANCOVA with the S-UPPS-P score at baseline as a covariate and the treatment arm as fixed factor.	Analysis based on the observation period: days 0 to 14, change from baseline calculated for Day 14.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Treatment Emergent Adverse Events and Serious Adverse Events	Treatment emergent adverse events are adverse events that occurred after treatment administration up to 4 days after the last dose of study drug.	From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 0352-2159; 2021-005270-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No