Attention Deficit Hyperactivity DisorderPhase 3ERESANCT01913912
Event Rate and Effects of Stimulants in ADHD
A Phase 3 study testing LDX., sugar pill and computer task (Go/No-Go task) in people with Attention Deficit Hyperactivity Disorder, run by University Ghent at 2 sites in Belgium.
Trial summary
Stimulants alleviate information processing and task performance deficits in Attention Deficit/Hyperactivity Disorder (ADHD). Long acting formulations of amphetamines such as lisdexamphetamine dimesylate (LDX) are especially valuable as they target the school day and improve classroom performance. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- LDX., sugar pill and computer task (Go/No-Go task)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2014to Jan 2014
- Phase
- Phase 3
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with ADHD (male and female)
- Age: form 7 years old until the end of 12 years old at screening
- Official diagnosis of ADHD (one of the three subtypes) as confirmed by administration of the Diagnostic Interview Scale for Children for DSM-IV (DISC-IV) interview at screening
- No prior use of stimulant medication (Drug naïve)
Who cannot join
- Comorbid disorders (severe anxiety or mood disorder, Autism Spectrum Disorder, Conduct disorder, Tic disorder, other major psychiatric pathologies)
- Other neurological disorder or chronic illness/disability
- Intelligence quotient (IQ) below 80
- Body weight below 22.7 kg
- Use of a psychoactive medication (especially use of monoamine oxidase inhibitors (MAOI))
- History of cardiac disease, family history of premature (sudden/unexpected) death in children or young adults, hypertrophic cardiomyopathy, clinically important arrhythmias including long QT syndrome (LQTS), Marfan syndrome
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- Abnormal findings on physical examination indicating cardiac disease
- Glaucoma
- Sensitive or allergic to stimulants or other ingredients of LDX
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ghent University Hospital
Ghent, 9000
Ghent University
Ghent, 9000
About this study
Official title: Can Changing the Rate at Which Information is Presented Alter the Effects of Stimulants on ADHD Information Processing. Testing a Prediction of the State Regulation Deficit Model.
Stimulants alleviate information processing and task performance deficits in Attention Deficit/Hyperactivity Disorder (ADHD). Long acting formulations of amphetamines such as lisdexamphetamine dimesylate (LDX) are especially valuable as they target the school day and improve classroom performance. Although stimulants have been widely used in treatment of ADHD, the exact mechanism action and effect on task performance is not completely known.
According to the State Regulation Deficit (SRD) model, children with ADHD have difficulty regulating their levels of arousal/activation during tasks in response to the changing demands of the environment. This leads to problems with downregulating overaroused states and upregulating underaroused states. According to this view, stimulants exert their therapeutic effect (in part) by optimising arousal/activation levels - especially during states of underarousal/activation. Arousal/activation levels can also be altered by extrinsic factors such as event rate (ER), e.g., the rate at which information is presented. Multiple studies suggest that very fast and very slow events can both cause problems for individuals with ADHD, related to overarousal and underarousal state respectively. Putting these intrinsic (stimulants) and extrinsic (ERs) factors together leads to the prediction that changing the rate at which information is presented in a task may alter the efficacy of stimulants and affect the optimal stimulant dose level. More specifically, one dose of stimulant that may be optimal on slow ER tasks (as it increases arousal/activation level) may be less effective under high ER tasks because in such a setting arousal/activation level needs to be lowered and not increased further. Adding stimulants to an already overactivated state may exacerbate the associated problems. The implication of this is that a different dose of stimulant will be needed under different environmental conditions for optimal performance. For example, children with ADHD might require different dosage in the classroom setting to optimize performance. In addition, the neuropsychological basis of performance deficits and improvement by ER and stimulants are also unclear. According to the SRD model, the underlying mechanism can be specific problems in motor activation/preparation or effort regulation. Event-related potentials (ERP), pupil size measurements and cardiac measures enable us to see objectively how motor activation/preparation and effort are affected by ER and simulants.
In this study the investigators aim to test these predictions of the SRD model and identify the neurobiological basis of stimulant action.
Read the detailed description
- Primary purpose: pathophysiology and basic science The aim of this study is to enlarge the knowledge of the mechanism action of long acting formulations of amphetamines and the neurobiological basis of stimulant action. Furthermore, this study aims to test the predictions of the State Regulation Deficit Model (SRD) for the effect of stimulant medication and presentation rate of stimuli on task performance of children with ADHD. The basic hypothesis is that performance of children with ADHD and the effect of stimulant medication will depend on task demands and the presentation rate of stimuli.
- Enrollment: number of Subjects: 25 children with ADHD (Anticipated)
- Study Phase: phase III
- Study Design: This study will comprise 5 phases. The expected total duration of the study trial is 10 weeks for each subject.
- Phase 1: screening (week 1) At the beginning of the study an extensive screening procedure will be undertaken. At the screening visit, a physician and a psychologist will ascertain the inclusion and exclusion criteria by using several instruments (questionnaires, parent interview, intelligence test). Furthermore, the physician will assess cardiac risks by taking the family history for cardiac disease and physical examination. Also the length, weight and blood pressure of the children will be monitored.
- Phase 2: titration (week 2 - 5) If the screening indicates that the child is eligible and the parents would like to start a medication treatment for their child, they can participate in a 4-week open-label titration of LDX. The aim of this stepwise titration procedure is to determine the child's clinically most effective dose. LDX will be started at a dose of 30mg/day and adjusted up to 70 mg/day if necessary. During the titration phase the parents will be asked to fill in a daily diary. Before the medication trial and at the end of each week of the medication trial, the investigators will measure symptom change and evaluate potential side effects of LDX. These assessments will include monitoring ADHD symptoms and physical examination for potential drug side effects. Furthermore, the physician will monitor weight, length, blood pressure and heart rate during each visit.
- Phase 3: maintenance of LDX (week 6 - 7) If the child benefits taking LDX, he/she will maintain his/her therapeutic dose for approximately two weeks.
- Phase 4: DBPC trial (week 8 - 9)
- Intervention model, group assignment: single group, cross-over design
- Number or arms (number of intervention groups): 2 arms, within-subject design (2 treatment conditions for each subject: active medication vs. placebo)
- Masking: double-blind (subjects, their parents and investigators will be blind to treatment conditions)
- Allocation: randomized
- Study end point classification: NA The investigators plan to use a randomized double-blind placebo-controlled crossover (DBPC) design. Children will be tested twice (once after the administration of the optimal dose of LDX and once after placebo) with a computer-based behavioral paradigm which measures efficient arousal modification in response to changing environmental settings. The investigators will use a Go/No-Go task with 4 different ERs (1 secs, 2secs, 4secs, 8secs). If children see an upright triangle (Go stimulus) they have to respond; if children see an inverted triangle (No-Go stimulus) they must withhold responding.
Parents, children and experimenters will be blind to treatment conditions. For blinding purpose we will blindfold the children when taking IMP or placebo (e.g. LDX and placebo capsules are not completely identical; however, the difference is barely noticeable when one is blindfolded). The order of the treatment conditions (LDX vs. placebo) will be randomly assigned and counterbalanced across children. Between the treatment conditions there will be an interval of approximately 1 week. During these intervals LDX intake will be continued. Before each testing session there will be a washout period of at least 48 hours; the LDX or placebo is given the morning of the testing. Each testing session will take place at the same time of day; preferably in the afternoon to minimalize possible time of day effects and approximately 3-4 hours after the child took LDX or placebo.
While children are performing the computer task, psychophysiological indices of effort and motor activation/preparation will be recorded: event-related potentials (ERP) (by using EEG), heart rate (by using EEG) and pupil size (by using eye tracking).
- Phase 5: follow-up visit (week 10) At the end of the DBPC trial, the drug will be stopped and the children will be evaluated after approximately 1 week of washout period for safety assessment. During this visit possible alternative treatments for ADHD can also be discussed.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- LDX., sugar pill, computer task (Go/No-Go task), EEG, pupil size measurements (by using eye tracking)
- 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.
LDX.Drug
Also called The European brandname is Elvance®
In this study 3 different doses of LDX will be used:
- 30 mg capsules: 30 mg LDX, equivalent to 8.9 mg of dexamphetamine
- 50 mg capsules: 50 mg LDX, equivalent to 14.8 mg of dexamphetamine
- 70 mg capsules: 70 mg LDX, equivalent to 20.8 mg of dexamphetamine
sugar pillDrug
Also called placebo
Children will take once only a placebo capsule during the DBPC phase (phase 4) the morning of the testing. For blinding purpose we will blindfold the children when taking placebo.
computer task (Go/No-Go task)Device
EEGDevice
event-related potentials (ERP) and heart rate measurements
pupil size measurements (by using eye tracking)Device
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine dimesylate (LDX) | Active comparator | Children will continue their therapeutic dose of LDX during the DBPC phase (which is determined during the titration phase). Before each testing session there will be a washout period of at least 48 hours; the optimal dose of LDX will be given the morning of the testing at the DRUG unit. For blinding purpose we will blindfold the children when taking LDX at the DRUG unit. Receives: Drug: LDX.; Device: computer task (Go/No-Go task); Device: EEG; Device: pupil size measurements (by using eye tracking) |
| Sugar pill | Placebo comparator | Children will continue their therapeutic dose of LDX during the DBPC phase (which is determined during the titration phase). Before each testing session there will be a washout period of at least 48 hours; the placebo will be given the morning of the testing at the DRUG unit. For blinding purpose we will blindfold the children when taking placebo at the DRUG unit. Receives: Drug: sugar pill; Device: computer task (Go/No-Go task); Device: EEG; Device: pupil size measurements (by using eye tracking) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance data (by using computerized Go-No Go task)
- mean reaction time (RT)
- standard deviation of reaction time (SDRT)
- errors of omissions (%EoO)
- errors of commission (%EoC)
Measured: 2 weeks (week 8-9 of the study)
psychophysiological data
- cardiac indices: heart rate variability (HRV), heart rate deviation (HRD) (by using EEG)
- electrophysiological indices: P3, LRP (lateralized readiness potential) (by using EEG)
- pupil size (by using eye-tracking)
Measured: 2 weeks (week 8-9 of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionJan 2014
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 University GhentThe 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Shire
- Responsible party
- Sponsor
- Investigators
- Rudy van Coster, MD, PhD, Principal investigator, University Hospital, GhentHerbert Roeyers, PhD, Principal investigator, University GhentEdmund Sonuga-Barke, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913912
- Sponsor's protocol ID
- EC/2013/481
- Other IDs
- 2013-001530-18
- Acronym
- ERESA
- Status last verified
- Nov 2021
- First submitted
- 30 Jul 2013
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Changing the Rate at Which Information is Presented Alter the Effects of Stimulants on ADHD Information Processing. Testing a Prediction of the State Regulation Deficit Model.
- ClinicalTrials.gov ID
- NCT01913912
- Acronym / sponsor ID
- ERESA / EC/2013/481
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Shire
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Aug 2013 (estimated)
- 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.
Stimulants alleviate information processing and task performance deficits in Attention Deficit/Hyperactivity Disorder (ADHD). Long acting formulations of amphetamines such as lisdexamphetamine dimesylate (LDX) are especially valuable as they target the school day and improve classroom performance. Although stimulants have been widely used in treatment of ADHD, the exact mechanism action and effect on task performance is not completely known.
According to the State Regulation Deficit (SRD) model, children with ADHD have difficulty regulating their levels of arousal/activation during tasks in response to the changing demands of the environment. This leads to problems with downregulating overaroused states and upregulating underaroused states. According to this view, stimulants exert their therapeutic effect (in part) by optimising arousal/activation levels - especially during states of underarousal/activation. Arousal/activation levels can also be altered by extrinsic factors such as event rate (ER), e.g., the rate at which information is presented. Multiple studies suggest that very fast and very slow events can both cause problems for individuals with ADHD, related to overarousal and underarousal state respectively. Putting these intrinsic (stimulants) and extrinsic (ERs) factors together leads to the prediction that changing the rate at which information is presented in a task may alter the efficacy of stimulants and affect the optimal stimulant dose level. More specifically, one dose of stimulant that may be optimal on slow ER tasks (as it increases arousal/activation level) may be less effective under high ER tasks because in such a setting arousal/activation level needs to be lowered and not increased further. Adding stimulants to an already overactivated state may exacerbate the associated problems. The implication of this is that a different dose of stimulant will be needed under different environmental conditions for optimal performance. For example, children with ADHD might require different dosage in the classroom setting to optimize performance. In addition, the neuropsychological basis of performance deficits and improvement by ER and stimulants are also unclear. According to the SRD model, the underlying mechanism can be specific problems in motor activation/preparation or effort regulation. Event-related potentials (ERP), pupil size measurements and cardiac measures enable us to see objectively how motor activation/preparation and effort are affected by ER and simulants.
In this study the investigators aim to test these predictions of the SRD model and identify the neurobiological basis of stimulant action.
Detailed description
- Primary purpose: pathophysiology and basic science The aim of this study is to enlarge the knowledge of the mechanism action of long acting formulations of amphetamines and the neurobiological basis of stimulant action. Furthermore, this study aims to test the predictions of the State Regulation Deficit Model (SRD) for the effect of stimulant medication and presentation rate of stimuli on task performance of children with ADHD. The basic hypothesis is that performance of children with ADHD and the effect of stimulant medication will depend on task demands and the presentation rate of stimuli.
- Enrollment: number of Subjects: 25 children with ADHD (Anticipated)
- Study Phase: phase III
- Study Design: This study will comprise 5 phases. The expected total duration of the study trial is 10 weeks for each subject.
- Phase 1: screening (week 1) At the beginning of the study an extensive screening procedure will be undertaken. At the screening visit, a physician and a psychologist will ascertain the inclusion and exclusion criteria by using several instruments (questionnaires, parent interview, intelligence test). Furthermore, the physician will assess cardiac risks by taking the family history for cardiac disease and physical examination. Also the length, weight and blood pressure of the children will be monitored.
- Phase 2: titration (week 2 - 5) If the screening indicates that the child is eligible and the parents would like to start a medication treatment for their child, they can participate in a 4-week open-label titration of LDX. The aim of this stepwise titration procedure is to determine the child's clinically most effective dose. LDX will be started at a dose of 30mg/day and adjusted up to 70 mg/day if necessary. During the titration phase the parents will be asked to fill in a daily diary. Before the medication trial and at the end of each week of the medication trial, the investigators will measure symptom change and evaluate potential side effects of LDX. These assessments will include monitoring ADHD symptoms and physical examination for potential drug side effects. Furthermore, the physician will monitor weight, length, blood pressure and heart rate during each visit.
- Phase 3: maintenance of LDX (week 6 - 7) If the child benefits taking LDX, he/she will maintain his/her therapeutic dose for approximately two weeks.
- Phase 4: DBPC trial (week 8 - 9)
- Intervention model, group assignment: single group, cross-over design
- Number or arms (number of intervention groups): 2 arms, within-subject design (2 treatment conditions for each subject: active medication vs. placebo)
- Masking: double-blind (subjects, their parents and investigators will be blind to treatment conditions)
- Allocation: randomized
- Study end point classification: NA The investigators plan to use a randomized double-blind placebo-controlled crossover (DBPC) design. Children will be tested twice (once after the administration of the optimal dose of LDX and once after placebo) with a computer-based behavioral paradigm which measures efficient arousal modification in response to changing environmental settings. The investigators will use a Go/No-Go task with 4 different ERs (1 secs, 2secs, 4secs, 8secs). If children see an upright triangle (Go stimulus) they have to respond; if children see an inverted triangle (No-Go stimulus) they must withhold responding.
Parents, children and experimenters will be blind to treatment conditions. For blinding purpose we will blindfold the children when taking IMP or placebo (e.g. LDX and placebo capsules are not completely identical; however, the difference is barely noticeable when one is blindfolded). The order of the treatment conditions (LDX vs. placebo) will be randomly assigned and counterbalanced across children. Between the treatment conditions there will be an interval of approximately 1 week. During these intervals LDX intake will be continued. Before each testing session there will be a washout period of at least 48 hours; the LDX or placebo is given the morning of the testing. Each testing session will take place at the same time of day; preferably in the afternoon to minimalize possible time of day effects and approximately 3-4 hours after the child took LDX or placebo.
While children are performing the computer task, psychophysiological indices of effort and motor activation/preparation will be recorded: event-related potentials (ERP) (by using EEG), heart rate (by using EEG) and pupil size (by using eye tracking).
- Phase 5: follow-up visit (week 10) At the end of the DBPC trial, the drug will be stopped and the children will be evaluated after approximately 1 week of washout period for safety assessment. During this visit possible alternative treatments for ADHD can also be discussed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine dimesylate (LDX) | Active comparator | Drug: LDX., Device: computer task (Go/No-Go task), Device: EEG, Device: pupil size measurements (by using eye tracking)Children will continue their therapeutic dose of LDX during the DBPC phase (which is determined during the titration phase). Before each testing session there will be a washout period of at least 48 hours; the optimal dose of LDX will be given the morning of the testing at the DRUG unit. For blinding purpose we will blindfold the children when taking LDX at the DRUG unit. |
| Sugar pill | Placebo comparator | Drug: sugar pill, Device: computer task (Go/No-Go task), Device: EEG, Device: pupil size measurements (by using eye tracking)Children will continue their therapeutic dose of LDX during the DBPC phase (which is determined during the titration phase). Before each testing session there will be a washout period of at least 48 hours; the placebo will be given the morning of the testing at the DRUG unit. For blinding purpose we will blindfold the children when taking placebo at the DRUG unit. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with ADHD (male and female)
- Age: form 7 years old until the end of 12 years old at screening
- Official diagnosis of ADHD (one of the three subtypes) as confirmed by administration of the Diagnostic Interview Scale for Children for DSM-IV (DISC-IV) interview at screening
- No prior use of stimulant medication (Drug naïve)
Key exclusion criteria (9 listed)
- Comorbid disorders (severe anxiety or mood disorder, Autism Spectrum Disorder, Conduct disorder, Tic disorder, other major psychiatric pathologies)
- Other neurological disorder or chronic illness/disability
- Intelligence quotient (IQ) below 80
- Body weight below 22.7 kg
- Use of a psychoactive medication (especially use of monoamine oxidase inhibitors (MAOI))
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 |
|---|---|---|
| LDX.Also: The European brandname is Elvance®In this study 3 different doses of LDX will be used: * 30 mg capsules: 30 mg LDX, equivalent to 8.9 mg of dexamphetamine * 50 mg capsules: 50 mg LDX, equivalent to 14.8 mg of dexamphetamine * 70 mg capsules: 70 mg LDX, equivalent to 20.8 mg of dexamphetamine | Drug | Lisdexamfetamine dimesylate (LDX) |
| sugar pillAlso: placeboChildren will take once only a placebo capsule during the DBPC phase (phase 4) the morning of the testing. For blinding purpose we will blindfold the children when taking placebo. | Drug | Sugar pill |
| computer task (Go/No-Go task) | Device | Lisdexamfetamine dimesylate (LDX), Sugar pill |
| EEGevent-related potentials (ERP) and heart rate measurements | Device | Lisdexamfetamine dimesylate (LDX), Sugar pill |
| pupil size measurements (by using eye tracking) | Device | Lisdexamfetamine dimesylate (LDX), Sugar pill |
Primary outcome
Performance data (by using computerized Go-No Go task)
Time frame: 2 weeks (week 8-9 of the study)
* mean reaction time (RT) * standard deviation of reaction time (SDRT) * errors of omissions (%EoO) * errors of commission (%EoC)
psychophysiological data
Time frame: 2 weeks (week 8-9 of the study)
* cardiac indices: heart rate variability (HRV), heart rate deviation (HRD) (by using EEG) * electrophysiological indices: P3, LRP (lateralized readiness potential) (by using EEG) * pupil size (by using eye-tracking)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 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.
Rudy van Coster, MD, PhD principal investigator
University Hospital, Ghent
Herbert Roeyers, PhD principal investigator
University Ghent
Edmund Sonuga-Barke, PhD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LDX., sugar pill and computer task (Go/No-Go task) in people with Attention Deficit Hyperactivity Disorder, run by University Ghent at 2 sites in Belgium.
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 4 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: withdrawn, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Performance data (by using computerized Go-No Go task) (time frame: 2 weeks (week 8-9 of the study)). The study lists 2 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 2 Dec 2021.