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

NCT05278104 | Completed Results

• 2 other identifiers: 0352-21592021-005270-26
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 5

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Percentage of Patients With Treatment Emergent Adverse Events and Serious Adverse Events

  From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days.

Study Arms (2)

Atomoxetine

EXPERIMENTAL

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®

Placebo (matching Atomoxetine)

PLACEBO COMPARATOR

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

Interventions

Zentiva® DRUG

Zentiva®, oral, tablet

Also known as: Atomoxetin

Atomoxetine

Placebo DRUG

Placebo, oral, tablet

Placebo (matching Atomoxetine)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (5)

Universitätsklinikum Aachen, AöR

Aachen, 52074, Germany

Location

Rheinhessen-Fachklinik Alzey

Alzey, 55232, Germany

Location

Universitätsklinikum Bonn AöR

Bonn, 53127, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60528, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 14, 2022
• Study Start: September 14, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 30, 2024
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)