Attention Deficit Hyperactivity DisorderCATNCT03942835
Psychometric Validation of the Competitive Attention Test
A study testing experience 1 : Competitive attention test in healthy participants, experience 2 : Competitive attention test in patients with ADHD with no treatment and experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment in people with Attention Deficit Hyperactivity Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This project aims at validating a new neuropsychological test to measure voluntary and involuntary attention for clinical use to diagnose attentional deficits. This project proposes: a test-retest procedure in healthy subjects aged from 6 to 90 year-old; testing in attention deficit hyperactivity disorder (ADHD)… Read more about this study
- Who is it for?
- Ages 6 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- experience 1 : Competitive attention test in healthy participants, experience 2 : Competitive attention test in patients with ADHD with no treatment and experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2020to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy major participants:
- Age from 18 to 90 year-old
- Informed consent to participate in the study
- No neurological or psychiatric disorder
- No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, attention deficit disorder
- healthy minor participants:
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- Age from 6 to 17 year-old
- Informed consent of parents or guardians for the child's participation in the study
- No neurological or psychiatric disorder
- No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, Attention deficit disorder
- ADHD minor patients:
- Age from 6 to 17 year-old
- Informed consent of parents or guardians for the child's participation in the study
- ADHD Diagnosis with or without hyperactivity
- No psychiatric history other than ADHD.
- For Experience 3: treatment in progress.
Who cannot join
- healthy major participants
- Age below 18 or above 90 year-old
- unaffiliated or non-beneficiaries of the social security scheme
- healthy minor participants:
- Age below 6 or above 18 year-old
- unaffiliated or non-beneficiaries of the social security scheme
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- ADHD minor patients:
- Age below 6 or above 18 year-old
- unaffiliated or non-beneficiaries of the social security scheme
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Neurosciences de Lyon, INSERM U1028
Bron, 69675
About this study
Official title: Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention
This project aims at validating a new neuropsychological test to measure voluntary and involuntary attention for clinical use to diagnose attentional deficits.
This project proposes:
- a test-retest procedure in healthy subjects aged from 6 to 90 year-old;
- testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment;
- testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- experience 1 : Competitive attention test in healthy participants, experience 2 : Competitive attention test in patients with ADHD with no treatment, experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment
- Keywords
- Attention Deficit Hyperactivity Disorder, attention, distraction, psychometric test, neuropsychological test validating procedure, psychostimulant
- 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.
experience 1 : Competitive attention test in healthy participantsOther
Comparison of behavioral measures (reaction times and percentage of correct responses) obtained twice with the CAT test in healthy participants (2 to 6 weeks apart).
experience 2 : Competitive attention test in patients with ADHD with no treatmentOther
Behavioral (reaction times and percentage of correct responses) and Electroencephalography (EEG) measures obtained with the CAT test in patients with ADHD with no treatment.
experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatmentOther
Behavioral (reaction times and percentage of correct responses) and EEG measures obtained with the CAT test in patients with ADHD before and after psychostimulant treatment.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants aged from 6 to 90 year-old | Experimental | Not described Receives: Other: experience 1 : Competitive attention test in healthy participants |
| patients with ADHD with no treatment | Experimental | patients with ADHD aged from 6 to 90 year-old with no treatment Receives: Other: experience 2 : Competitive attention test in patients with ADHD with no treatment |
| patients with ADHD with treatment | Experimental | patients with ADHD aged from 6 to 90 year-old with psychostimulant treatment (Methylphenidate) Receives: Other: experience 2 : Competitive attention test in patients with ADHD with no treatment; Other: experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction times in healthy subjects and patients with ADHD.
Reaction times in milliseconds obtained with the CAT test in healthy participants and in patients with ADHD.
Measured: 6 weeks
Secondary outcomes (1)
Percentage of correct responses in healthy subjects and patients with ADHD.
Percentage of correct responses obtained with the CAT test in healthy participants and in patients with ADHD.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start21 Jan 2020
- Primary completion20 Mar 2021
- Study completion20 Apr 2021
Why it stopped: abandonment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942835
- Sponsor's protocol ID
- 69HCL18_0376
- Other IDs
- 2018-A02597-48
- Acronym
- CAT
- Status last verified
- Oct 2021
- First submitted
- 30 Apr 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention
- ClinicalTrials.gov ID
- NCT03942835
- Acronym / sponsor ID
- CAT / 69HCL18_0376
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, attention, distraction, psychometric test, neuropsychological test validating procedure, psychostimulant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: abandonment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 8 May 2019 (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.
This project aims at validating a new neuropsychological test to measure voluntary and involuntary attention for clinical use to diagnose attentional deficits.
This project proposes:
- a test-retest procedure in healthy subjects aged from 6 to 90 year-old;
- testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment;
- testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy participants aged from 6 to 90 year-old | Experimental | Other: experience 1 : Competitive attention test in healthy participants |
| patients with ADHD with no treatment | Experimental | Other: experience 2 : Competitive attention test in patients with ADHD with no treatmentpatients with ADHD aged from 6 to 90 year-old with no treatment |
| patients with ADHD with treatment | Experimental | Other: experience 2 : Competitive attention test in patients with ADHD with no treatment, Other: experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatmentpatients with ADHD aged from 6 to 90 year-old with psychostimulant treatment (Methylphenidate) |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Age from 18 to 90 year-old
- Informed consent to participate in the study
- No neurological or psychiatric disorder
- No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, attention deficit disorder
- Age from 6 to 17 year-old
Key exclusion criteria (9 listed)
- healthy major participants
- Age below 18 or above 90 year-old
- unaffiliated or non-beneficiaries of the social security scheme
- Age below 6 or above 18 year-old
- unaffiliated or non-beneficiaries of the social security scheme
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 |
|---|---|---|
| experience 1 : Competitive attention test in healthy participantsComparison of behavioral measures (reaction times and percentage of correct responses) obtained twice with the CAT test in healthy participants (2 to 6 weeks apart). | Other | Healthy participants aged from 6 to 90 year-old |
| experience 2 : Competitive attention test in patients with ADHD with no treatmentBehavioral (reaction times and percentage of correct responses) and Electroencephalography (EEG) measures obtained with the CAT test in patients with ADHD with no treatment. | Other | patients with ADHD with no treatment, patients with ADHD with treatment |
| experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatmentBehavioral (reaction times and percentage of correct responses) and EEG measures obtained with the CAT test in patients with ADHD before and after psychostimulant treatment. | Other | patients with ADHD with treatment |
Primary outcome
Reaction times in healthy subjects and patients with ADHD.
Time frame: 6 weeks
Reaction times in milliseconds obtained with the CAT test in healthy participants and in patients with ADHD.
1 secondary outcome
Percentage of correct responses in healthy subjects and patients with ADHD.
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: abandonment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experience 1 : Competitive attention test in healthy participants, experience 2 : Competitive attention test in patients with ADHD with no treatment and experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment in people with Attention Deficit Hyperactivity Disorder, run by Hospices Civils de Lyon at 1 site in France.
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 16 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 Nov 2021. 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 France. 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?
The study was stopped early (reason given: abandonment). Results are not available in the source record.
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?
Reaction times in healthy subjects and patients with ADHD. (time frame: 6 weeks). 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 1 Nov 2021.