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

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • Universitätsklinikum Aachen, AöR
    • Contact: Boehringer Ingelheim; Phone Number: 08007234742; Email: deutschland@bitrialsupport.com
  • Alzey, Germany, 55232
    • Recruiting
    • Rheinhessen-Fachklinik Alzey
    • Contact: Boehringer Ingelheim; Phone Number: 08007234742; Email: deutschland@bitrialsupport.com
  • Bonn, Germany, 53127
    • Recruiting
    • Universitätsklinikum Bonn AöR
    • Contact: Boehringer Ingelheim; Phone Number: 08007234742; Email: deutschland@bitrialsupport.com
  • Frankfurt, Germany, 60528
    • Recruiting
    • Universitatsklinikum Frankfurt
    • Contact: Boehringer Ingelheim; Phone Number: 08007234742; Email: deutschland@bitrialsupport.com
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitatsklinikum Leipzig
    • Contact: Boehringer Ingelheim; Phone Number: 08007234742; Email: deutschland@bitrialsupport.com

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
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: Atomoxetine	Drug: Zentiva®; Zentiva®; Other Names: Atomoxetin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in total score of Barratt Impulsiveness Questionnaire version 11 (BIS-11) after single dose	The total BIS-11 score ranges from 30 to 120 with a higher score indicating an increased impulsive behavior.	at day 1
Change from baseline in total score of Barratt Impulsiveness Questionnaire BIS-11 at steady state	The total BIS-11 score ranges from 30 to 120 with a higher score indicating an increased impulsive behavior.	at day 14
Change from baseline in total score of S-UPPS-P Impulsive Behavior Scale after single dose	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.	at day 1
Change from baseline in total score of S-UPPS-P Impulsive Behavior Scale at steady state	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.	at day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with (serious) adverse events.	up to 28 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): September 20, 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): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• 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