Attention Deficit Hyperactivity DisorderNCT05278104
A Study to Test Different Ways to Measure the Effect of Atomoxetine on Impulsive Behavior in Young Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Zentiva® in people with Attention Deficit Hyperactivity Disorder, run by Boehringer Ingelheim at 5 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Zentiva®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 5 sitesGermany
- Study dates
- 14 Sep 2023to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Universitätsklinikum Aachen, AöR
Aachen, 52074
Rheinhessen-Fachklinik Alzey
Alzey, 55232
Universitätsklinikum Bonn AöR
Bonn, 53127
Universitätsklinikum Frankfurt
Frankfurt, 60528
Universitätsklinikum Leipzig
Leipzig, 04103
About this study
Official title: 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Zentiva®, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zentiva®Drug
Also called Atomoxetin
Zentiva®, oral, tablet
PlaceboDrug
Placebo, oral, tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Treatment emergent adverse events are adverse events that occurred after treatment administration up to 4 days after the last dose of study drug.
Measured: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start14 Sep 2023
- Primary completion23 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278104
- Sponsor's protocol ID
- 0352-2159
- Other IDs
- 2021-005270-26
- Status last verified
- Oct 2025
- First submitted
- 11 Mar 2022
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05278104
- Acronym / sponsor ID
- 0352-2159
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Posted 14 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Experimental | Drug: Zentiva®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. |
| Placebo (matching Atomoxetine) | Placebo comparator | Drug: PlaceboDay 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zentiva®Also: AtomoxetinZentiva®, oral, tablet | Drug | Atomoxetine |
| PlaceboPlacebo, oral, tablet | Drug | Placebo (matching Atomoxetine) |
Primary outcome
Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) After Single Dose (at Day 1)
Time frame: 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 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.
Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) at Steady State (at Day 14)
Time frame: 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 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.
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)
Time frame: 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 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.
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)
Time frame: 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 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.
1 secondary outcome
Percentage of Patients With Treatment Emergent Adverse Events and Serious Adverse Events
Time frame: From first drug administration on Day 1 until Day 16 + 4 days (REP), up to 20 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zentiva® in people with Attention Deficit Hyperactivity Disorder, run by Boehringer Ingelheim at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total Score of Barratt Impulsiveness Questionnaire v.11 (BIS-11) After Single Dose (at Day 1) (time frame: Analysis based on the observation period: days 0 to 1, change from baseline calculated for Day 1.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.