ADHD - Attention Deficit Disorder With HyperactivityDS-ADHD1NCT06910605
Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients
A study testing "drug holidays" (D) in people with ADHD - Attention Deficit Disorder With Hyperactivity and Driving Simulator Performance, run by Stefan Lakämper at 1 site in Switzerland.
Trial summary
Attention deficit hyperactivity disorder (ADHD) or syndrome (ADHS) is a symptomatically defined condition that - if untreated - is linked to a significantly increased risk of traffic accidents. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity, Driving Simulator Performance, ADHD
- What is being tested?
- "drug holidays" (D)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jun 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult drivers
- ADHD-diagnosed, established ADHD-treatment only with stimulants
- known history of drug holidays based on own decision,
- at impaired eyesight with more than +/- 5 diopter or astigmatism
- contact lenses are required (for eye tracking)
Who cannot join
- sensibility to motion sickness (kinetosis, dizziness etc. in 5 min screening drive)
- non-stimulant-treatment
- inability to understand the study procedure for linguistic or cognitive reasons
- professional drivers (if working during the study period)
- for women: pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Division of Traffic Medicine, Institute of Forensic Medicine, University of Zurich,
Zurich, ZRH, 8050
Stefan Lakämper, Dr. rer. nat., +41793789984, stefan.lakaemper@irm.uzh.ch
Nan Li, MSc, nan.li@irm.uzh.ch
About this study
Attention deficit hyperactivity disorder (ADHD) or syndrome (ADHS) is a symptomatically defined condition that - if untreated - is linked to a significantly increased risk of traffic accidents. In a recent umbrella review, where data from reviews and meta-analyses on 21.142.129 adults was assessed, a pooled prevalence of 3.1% of ADHD in adults was estimated. Considering that globally around 1.35 million people lose their lives and more than 50 million are suffering from injuries or disabilities due to road accidents, the fraction of car accidents caused by ADHD as a risk factor is considerable and needs to be addressed. This risk is largely presumed to be caused by an elevated level of inattentiveness in affected persons.
Compounds of different groups, which can be classified in stimulants - formulations of methylphenidate and amphetamine - and non-stimulants - atomoxetin, guanfacine and clonidine -, have been shown to be effective in alleviating negative effects of ADHD, including inattentiveness. Under well-established but individually managed medication regimes, affected individuals can consequently lead a largely "unirritated" life and are not subject to fundamental restriction with respect to driving anymore.
Read more
In children and adolescents, documented negative effects of stimulant medication include loss of appetite and decreased growth rates. It could however be shown that short-term interruptions (weekend, school holidays, and alike), introduced to alleviate aforementioned effects, do not affect the drug's beneficial effects in functional use (e.g., school). Such monitored medication breaks are often called "drug holidays" (D). They have become standard procedure in well-monitored treatment, predominantly including behavioral therapy.
Based on own experience in childhood and or hearsay, also a fraction of affected adults under stimulant medication expresses the desire to take drug holidays and "be themselves" from time to time. With the predominant fraction of medication being fast acting drugs in extended-release formulation and typical patients being not only highly compliant but also extremely informed and adherent, these so-called "drug holidays" are reported an accepted in therapeutically accompanied settings of adults by now.
However, while the overall positive effect of stimulant treatment on driving performance has been confirmed in a row of excellent on road- and/or simulation studies using integrated driving scores (IDS), so far there is no study available addressing the effect of drug holidays in adult drivers on driving performance. This represents a significant gap of evidence for both medical experts and affected.
The proposed study will address this gap by exploring parameters of driving simulation in relation to drug holidays in ADHD patients.
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity, Driving Simulator Performance, ADHD, Driving Behavior, Driving Ability
- Being tested
- "drug holidays" (D)
- Keywords
- driving simulation, driving performance, eye tracking, EEG-recording, stimulant treatment, drug holidays
- 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.
"drug holidays" (D)Drug
Participants omit three consecutive daily doses of ADHD-medication (stimulant).
| Study group | Role | What they receive |
|---|---|---|
| Group 1: M-M-D | Experimental | stimulant-treated ADHD-affected participants will perform test sequence first in medicated state (M), then again in medicated state (M), then during "drug holidays" (D). Receives: Drug: "drug holidays" (D) |
| Group 2: M-D-M | Experimental | stimulant-treated ADHD-affected participants will perform test sequence first in medicated state (M), then during "drug holidays" (D), then again in medicated state (M). Receives: Drug: "drug holidays" (D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant differences in IDS between conditions D and M
Primary outcome parameter IDS (Integrated Driving Score) will be calculated by summation of z-scores of typical driving parameters such as, for example, the standard deviation of lane position (SDLP), standard deviation of velocity (SDS) or number of inappropriate lane departures, ILD. IDS will be measured on day 0 (= baseline, Visit 1), on day x (with x≥4, Visit 2) and on day x+3 (Visit 3).
Measured: 0, x, x+3 days, with x≥ 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start2 Jun 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- monocentric, within-subjects, observer-blinded cross-over trial (within-subject randomized crossover trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefan Lakämper
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Swiss Federal Institute of Technology in Zurich (ETHZ)
- Responsible party
- Sponsor-investigator, Stefan Lakämper, University of Zurich
- Investigators
- Stefan Lakämper, Dr. rer. nat., Principal investigator, University of ZurichKristina Keller, Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910605
- Sponsor's protocol ID
- DS-ADHD1
- Acronym
- DS-ADHD1
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be published in peer-reviewed journals. Anonymized raw data will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Parameters of Driving Simulation in Relation to Drug Holidays in ADHD Patients
- ClinicalTrials.gov ID
- NCT06910605
- Acronym / sponsor ID
- DS-ADHD1 / DS-ADHD1
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity, Driving Simulator Performance, ADHD, Driving Behavior, Driving Ability
- Keywords
- driving simulation, driving performance, eye tracking, EEG-recording, stimulant treatment, drug holidays
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Stefan LakämperUniversity, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Swiss Federal Institute of Technology in Zurich (ETHZ)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Attention deficit hyperactivity disorder (ADHD) or syndrome (ADHS) is a symptomatically defined condition that - if untreated - is linked to a significantly increased risk of traffic accidents. In a recent umbrella review, where data from reviews and meta-analyses on 21.142.129 adults was assessed, a pooled prevalence of 3.1% of ADHD in adults was estimated. Considering that globally around 1.35 million people lose their lives and more than 50 million are suffering from injuries or disabilities due to road accidents, the fraction of car accidents caused by ADHD as a risk factor is considerable and needs to be addressed. This risk is largely presumed to be caused by an elevated level of inattentiveness in affected persons.
Compounds of different groups, which can be classified in stimulants - formulations of methylphenidate and amphetamine - and non-stimulants - atomoxetin, guanfacine and clonidine -, have been shown to be effective in alleviating negative effects of ADHD, including inattentiveness. Under well-established but individually managed medication regimes, affected individuals can consequently lead a largely "unirritated" life and are not subject to fundamental restriction with respect to driving anymore.
In children and adolescents, documented negative effects of stimulant medication include loss of appetite and decreased growth rates. It could however be shown that short-term interruptions (weekend, school holidays, and alike), introduced to alleviate aforementioned effects, do not affect the drug's beneficial effects in functional use (e.g., school). Such monitored medication breaks are often called "drug holidays" (D). They have become standard procedure in well-monitored treatment, predominantly including behavioral therapy.
Based on own experience in childhood and or hearsay, also a fraction of affected adults under stimulant medication expresses the desire to take drug holidays and "be themselves" from time to time. With the predominant fraction of medication being fast acting drugs in extended-release formulation and typical patients being not only highly compliant but also extremely informed and adherent, these so-called "drug holidays" are reported an accepted in therapeutically accompanied settings of adults by now.
However, while the overall positive effect of stimulant treatment on driving performance has been confirmed in a row of excellent on road- and/or simulation studies using integrated driving scores (IDS), so far there is no study available addressing the effect of drug holidays in adult drivers on driving performance. This represents a significant gap of evidence for both medical experts and affected.
The proposed study will address this gap by exploring parameters of driving simulation in relation to drug holidays in ADHD patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- monocentric, within-subjects, observer-blinded cross-over trial (within-subject randomized crossover trial
| Arm | Type | Receives |
|---|---|---|
| Group 1: M-M-D | Experimental | Drug: "drug holidays" (D)stimulant-treated ADHD-affected participants will perform test sequence first in medicated state (M), then again in medicated state (M), then during "drug holidays" (D). |
| Group 2: M-D-M | Experimental | Drug: "drug holidays" (D)stimulant-treated ADHD-affected participants will perform test sequence first in medicated state (M), then during "drug holidays" (D), then again in medicated state (M). |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- adult drivers
- ADHD-diagnosed, established ADHD-treatment only with stimulants
- known history of drug holidays based on own decision,
- at impaired eyesight with more than +/- 5 diopter or astigmatism
- contact lenses are required (for eye tracking)
Key exclusion criteria (5 listed)
- sensibility to motion sickness (kinetosis, dizziness etc. in 5 min screening drive)
- non-stimulant-treatment
- inability to understand the study procedure for linguistic or cognitive reasons
- professional drivers (if working during the study period)
- for women: pregnancy
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 |
|---|---|---|
| "drug holidays" (D)Participants omit three consecutive daily doses of ADHD-medication (stimulant). | Drug | Group 1: M-M-D, Group 2: M-D-M |
Primary outcome
Significant differences in IDS between conditions D and M
Time frame: 0, x, x+3 days, with x≥ 4 days
Primary outcome parameter IDS (Integrated Driving Score) will be calculated by summation of z-scores of typical driving parameters such as, for example, the standard deviation of lane position (SDLP), standard deviation of velocity (SDS) or number of inappropriate lane departures, ILD. IDS will be measured on day 0 (= baseline, Visit 1), on day x (with x≥4, Visit 2) and on day x+3 (Visit 3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Yes. Results will be published in peer-reviewed journals. Anonymized raw data will be made available upon request.
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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.
Stefan Lakämper, Dr. rer. nat. principal investigator
University of Zurich
Kristina Keller, Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "drug holidays" (D) in people with ADHD - Attention Deficit Disorder With Hyperactivity and Driving Simulator Performance, run by Stefan Lakämper at 1 site in Switzerland.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Lakämper, Dr. rer. nat. (+41793789984, stefan.lakaemper@irm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant differences in IDS between conditions D and M (time frame: 0, x, x+3 days, with x≥ 4 days). 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 5 Jun 2025.