A Study to Test Different Ways to Measure the Effect of Atomoxetine on Impulsive Behavior in Young Adults With Attention Deficit Hyperactivity Disorder (ADHD)
CompletedNAResults postedLast updated 14 November 2025
What this trial tests
NA trial testing Zentiva® in Attention Deficit Hyperactivity Disorder in 63 participants. Completed in 30 October 2024.
Adults 18 to 45, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) After Single Dose (at Day 1)Primary· Analysis based on the observation period: days 0 to 1, change from baseline calculated for 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
Group
Value
95% CI
Atomoxetine
-0.8
-2.3 – 0.8
Placebo (Matching Atomoxetine)
-0.4
-1.9 – 1.1
Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) at Steady State (at Day 14)Primary· Analysis based on the observation period: days 0 to 14, change from baseline calculated for 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
Group
Value
95% CI
Atomoxetine
-2.3
-4.1 – -0.5
Placebo (Matching Atomoxetine)
-0.1
-1.9 – 1.6
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)Primary· Analysis based on the observation period: days 0 to 1, change from baseline calculated for 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 da
Group
Value
95% CI
Atomoxetine
0.0
-1.6 – 1.6
Placebo (Matching Atomoxetine)
-0.1
-1.7 – 1.4
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)Primary· Analysis based on the observation period: days 0 to 14, change from baseline calculated for 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 da
Group
Value
95% CI
Atomoxetine
-0.2
-1.7 – 1.4
Placebo (Matching Atomoxetine)
-1.0
-2.5 – 0.5
Percentage of Patients With Treatment Emergent Adverse Events and Serious Adverse EventsSecondary· From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days.
Treatment emergent adverse events are adverse events that occurred after treatment administration up to 4 days after the last dose of study drug.
Treatment-emergent adverse events
Group
Value
95% CI
Atomoxetine
90.3
Placebo (Matching Atomoxetine)
80.6
Treatment-emergent serious adverse events
Group
Value
95% CI
Atomoxetine
0
Placebo (Matching Atomoxetine)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days. All-cause mortality: From first drug administration on Day 1 until Day 28, up to 28 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Other recruiting trials for Attention Deficit Hyperactivity Disorder
Currently open trials in the same condition.
NCT07001475 — A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperact
· Phase 1
· recruiting
NCT06847165 — Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
· NA
· recruiting
NCT06248229 — A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder
· Phase 4
· recruiting
NCT06232226 — Attention Deficit Hyperactivity Disorder
· NA
· recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 14 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05278104.