Attention Deficit Disorder With HyperactivityADHDNCT04823364
Evaluation of Brain Neurotransmitter Levels in Adults With ADHD, Before and After Stimulant Treatment
A study testing Neurotransmitters evaluation by MRS in people with Attention Deficit Disorder With Hyperactivity, run by Weizmann Institute of Science at 2 sites in Israel.
Trial summary
Background: Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neurobiological brain disorders. Diagnosis of ADHD in adults is complex and subjective. Recent studies give further support for the involvement of glutamatergic and GABAergic neurotransmitters in the pathophysiology of ADHD. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Neurotransmitters evaluation by MRS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIsrael
- Study dates
- 11 Jul 2024to 11 Jul 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Giving informed written consent to participate on a voluntary basis.
- For the healthy control group:
- Men and women aged 18-40 years, who did not report ADHD or any other chronic or psychiatric illness or medical conditions (at most two symptoms of inattention and/or hyperactivity/impulsivity).
- For the ADHD group patients:
- Men and women aged 18-40 years, who have a diagnosis of ADHD, according to DSM V criteria by a Neurologist.
- Have a valid prescription for Mixed Amphetamine salts (Attent) or short-acting methylphenidate (Ritalin) for ADHD
- Withhold medication 72h prior to MRS scan.
Who cannot join
- Exclusion criteria identical for patients and control group:
- Subjects with metallic devices that precludemagnetic resonance imaging or any silver part that is not MRI compliant
- Current presence of any other DSM V psychiatric disorder
- Significant medical or neurological illness affecting brain function
- Subjects with any clinically significant or unstable medical conditions
- Use of any psychotropic medication, other than stimulants, in the previous 3 months
Show all 12Show fewer
- Pregnant women
- BMI > 35
- History of brain MRI
- A patient who does not agree that the scan will be decoded by a radiologist
- A patient who does not agree that in case of an abnormal finding, the imaging results will be forwarded to the attending physician for further clarification
- Understanding and/or language problems
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Measuring Glutamate and GABA Brain Levels in Adults With Attention Deficit Hyperactivity Disorder (ADHD) Using Magnetic Resonance Spectroscopy (MRS)
Background:
Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neurobiological brain disorders. Diagnosis of ADHD in adults is complex and subjective. Recent studies give further support for the involvement of glutamatergic and GABAergic neurotransmitters in the pathophysiology of ADHD. Studies show that glutamate (Glu) and GABA change according to stimulant treatment. Measuring modulations in the anterior cingulate cortex (ACC) of Glu and GABA may help to explore the pathophysiology of ADHD and give a diagnostic biomarker tool for ADHD in adults.
Read more
Aim:
To characterize Glu and GABA levels in the ACC, by using the proton Magnetic Resonance Spectroscopy ([1H]MRS) system in adults with ADHD compared to healthy control subjects (HCS), before and after stimulant treatment, and to correlate between Glu and GABA levels and clinical symptoms.
Method:
ADHD adults ages 18-40 years (N= 35), and HCS (N= 25), will fill out a DSMV and ASRS questionnaire.
Spectroscopic analyses will be done using 1H MRS (3T) in ADHD adults, before and after stimulant treatment (Methylphenidate /Mixed Amphetamine salts) in an open-label fashion as compared to HCS. Proton spectra will be acquired from the ACC.
Read the detailed description
Hypothesis:
- We hypothesize that brain Glu and GABA levels and/or their ratio involved in ADHD pathology
- Glu and GABA levels and/or their ratio will be affected by medical treatment in ADHD group
- Alteration of Glu and GABA and/or their ratios, before and after treatment, will correlate with clinical response to treatment
Primary Objectives:
To characterize changes in Glu and GABA levels in the ACC of adults with ADHD compared to the healthy subjects To characterize Glu and GABA levels in the ACC of adults with ADHD before and 1.5 hrs. after stimulant treatment using 1H MRS system.
Secondary objective:
To study the correlation between Glu and GABA levels in ADHD patients (before and after medical treatment) and clinical symptoms as assessed by ASRS and DSMV and/or NeuroTrax Braincare computerized test
Design and study population:
This is a prospective observational, open-label, comparative study that is approved by the Institutional Review Board (IRB) of Maccabi Healthcare services and the Ethical Committee of Tel Aviv University, in collaboration with the Weizmann Institute of Science. Medically healthy ADHD adults of ages 18-40 years (N= 35), and matched HCS (N= 25) will be recruited.
Procedure ADHD Participants will be enrolled from the Maccabi database. Volunteers will be enrolled as a Control group
- Pre-assessment questionnaires including epidemiologic data, DSMV, and Adult ADHD Self-Report Scale (ASRS) will be filled out.
- Detailed explanation will be given of the trial objectives, trial methods and risks or possible discomfort that may result from an MRI/MRS examination
- During screening, subjects will receive information regarding the study, including general eligibility criteria, study design, procedures and duration. Subjects will have the opportunity to ask questions and will undergo an informed consent procedure. Subjects meeting inclusion/exclusion criteria will be enrolled. The participant will sign an informed consent form and will receive a copy.
After screening, participants who meet the inclusion criteria will be invited to the center for Computational Neuroimaging at Weizmann Institute of Science to perform the MRS scan.
ADHD patients will be instructed not to take medication for at least 72 hours prior to their arrival and will be asked to bring their medical drug treatment.
All participants will go through spectroscopic analyses using 1H MRS (at 3 Tesla) Control group participants will go through MRS once and complete their study. Adults with ADHD will repeat MRS screening, 1.5 hours after taking their medical treatment (Methylphenidate /Mixed Amphetamine salts).
Study population:
Medically healthy adults diagnosed with ADHD (men and women) ages 18-40 years (N= 35), treated with Amphetamines (Mixed Amphetamine salts (Attent) or short-acting methylphenidate (Ritalin)) will be enrolled from the Maccabi database. Matched HCS (N= 25) volunteers ages 18-40 years, who did not report ADHD or any other illness or medical conditions, and who do not take chronic medications, will be enrolled from the general population.
The Adult ADHD Self-Report Scale and DSMV questionnaire will be used to determine ADHD symptoms in both groups.
- Being tested
- Neurotransmitters evaluation by MRS
- Keywords
- ACC, methylphenidate, MRS, Glutamate, GABA
- 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.
Neurotransmitters evaluation by MRSOther
Baseline MRS screening for volunteers and ADHD groups and repeated measurement for ADHD group after taking stimulant drug treatment
| Study group | Role | What they receive |
|---|---|---|
| Medically healthy adults diagnosed with ADHD | Active comparator | Medically healthy adults diagnosed with ADHD (men and women) ages 18-40 years (N= 35), treated with Amphetamines (Mixed Amphetamine salts (Attent) or short-acting methylphenidate (Ritalin) Receives: Other: Neurotransmitters evaluation by MRS |
| Control | No intervention | HCS (N= 25) volunteers ages 18-40 years, who did not report ADHD or any other illness or medical conditions, and who do not take chronically medications, will be enrolled from the general population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glu and GABA levels measured by MRS in ACC brain area
Differences in levels of Glu and GABA in ADHD patients compared to healthy volunteers
Measured: 72 hours without stimulant
Glu and GABA levels measured by MRS in ACC brain area before and after medical treatment
Differences in levels of Glu and GABA measured before and after medical treatment.
Measured: 90 minutes after stimulant
Secondary outcomes (1)
Correlation of Glu and GABA levels with clinical symptoms before and after stimulants
Analysis of correlation of Glu and GABA levels with post/previous clinical manifestation evaluated by Neuro Trax Braincare test and/or ASRS and DSMV questionnaire.
Measured: 210 minutes after stimulant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start11 Jul 2024
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Why it stopped: Professor Assaf Tal left Weizmann Institute
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 control healthy people Group 2 ADHD
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weizmann Institute of Science
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University, Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor
- Investigators
- Assaf Tal, PhD., Study chair, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823364
- Sponsor's protocol ID
- 0109-19-MOH
- Acronym
- ADHD
- Status last verified
- Jul 2022
- First submitted
- 25 Mar 2021
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We would wish to make our results available both to the community of scientists interested in ADHD and the biology to avoid unintentional duplication of research. Conversely, we would welcome collaboration with others who could make use of the H-MRS protocols developed in psychiatric disease. Any patient-level data that is shared will be anonymized to protect personally identifiable information.
Publications
Naaijen J, Lythgoe DJ, Amiri H, Buitelaar JK, Glennon JC. Fronto-striatal glutamatergic compounds in compulsive and impulsive syndromes: a review of magnetic resonance spectroscopy studies. Neurosci Biobehav Rev. 2015 May;52:74-88. doi: 10.1016/j.neubiorev.2015.02.009. Epub 2015 Feb 21.
PubMed 25712432Maltezos S, Horder J, Coghlan S, Skirrow C, O'Gorman R, Lavender TJ, Mendez MA, Mehta M, Daly E, Xenitidis K, Paliokosta E, Spain D, Pitts M, Asherson P, Lythgoe DJ, Barker GJ, Murphy DG. Glutamate/glutamine and neuronal integrity in adults with ADHD: a proton MRS study. Transl Psychiatry. 2014 Mar 18;4(3):e373. doi: 10.1038/tp.2014.11.
PubMed 24643164Ende G, Cackowski S, Van Eijk J, Sack M, Demirakca T, Kleindienst N, Bohus M, Sobanski E, Krause-Utz A, Schmahl C. Impulsivity and Aggression in Female BPD and ADHD Patients: Association with ACC Glutamate and GABA Concentrations. Neuropsychopharmacology. 2016 Jan;41(2):410-8. doi: 10.1038/npp.2015.153. Epub 2015 Jun 4.
PubMed 26040503Bauer J, Werner A, Kohl W, Kugel H, Shushakova A, Pedersen A, Ohrmann P. Hyperactivity and impulsivity in adult attention-deficit/hyperactivity disorder is related to glutamatergic dysfunction in the anterior cingulate cortex. World J Biol Psychiatry. 2018 Oct;19(7):538-546. doi: 10.1080/15622975.2016.1262060. Epub 2016 Dec 15.
PubMed 27973969Perlov E, Philipsen A, Hesslinger B, Buechert M, Ahrendts J, Feige B, Bubl E, Hennig J, Ebert D, Tebartz van Elst L. Reduced cingulate glutamate/glutamine-to-creatine ratios in adult patients with attention deficit/hyperactivity disorder -- a magnet resonance spectroscopy study. J Psychiatr Res. 2007 Dec;41(11):934-41. doi: 10.1016/j.jpsychires.2006.12.007. Epub 2007 Feb 15.
PubMed 17303167Endres D, Perlov E, Maier S, Feige B, Nickel K, Goll P, Bubl E, Lange T, Glauche V, Graf E, Ebert D, Sobanski E, Philipsen A, Tebartz van Elst L. Normal Neurochemistry in the Prefrontal and Cerebellar Brain of Adults with Attention-Deficit Hyperactivity Disorder. Front Behav Neurosci. 2015 Sep 28;9:242. doi: 10.3389/fnbeh.2015.00242. eCollection 2015.
PubMed 26441572Bezalel V, Paz R, Tal A. Inhibitory and excitatory mechanisms in the human cingulate-cortex support reinforcement learning: A functional Proton Magnetic Resonance Spectroscopy study. Neuroimage. 2019 Jan 1;184:25-35. doi: 10.1016/j.neuroimage.2018.09.016. Epub 2018 Sep 7.
PubMed 30201464
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Glutamate and GABA Brain Levels in Adults With Attention Deficit Hyperactivity Disorder (ADHD) Using Magnetic Resonance Spectroscopy (MRS)
- ClinicalTrials.gov ID
- NCT04823364
- Acronym / sponsor ID
- ADHD / 0109-19-MOH
- Keywords
- ACC, methylphenidate, MRS, Glutamate, GABA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Professor Assaf Tal left Weizmann Institute
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Weizmann Institute of ScienceUniversity, hospital or other
- Collaborators
- Tel Aviv University, Maccabi Healthcare Services, Israel
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 30 Mar 2021 (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.
Background:
Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neurobiological brain disorders. Diagnosis of ADHD in adults is complex and subjective. Recent studies give further support for the involvement of glutamatergic and GABAergic neurotransmitters in the pathophysiology of ADHD. Studies show that glutamate (Glu) and GABA change according to stimulant treatment. Measuring modulations in the anterior cingulate cortex (ACC) of Glu and GABA may help to explore the pathophysiology of ADHD and give a diagnostic biomarker tool for ADHD in adults.
Aim:
To characterize Glu and GABA levels in the ACC, by using the proton Magnetic Resonance Spectroscopy ([1H]MRS) system in adults with ADHD compared to healthy control subjects (HCS), before and after stimulant treatment, and to correlate between Glu and GABA levels and clinical symptoms.
Method:
ADHD adults ages 18-40 years (N= 35), and HCS (N= 25), will fill out a DSMV and ASRS questionnaire.
Spectroscopic analyses will be done using 1H MRS (3T) in ADHD adults, before and after stimulant treatment (Methylphenidate /Mixed Amphetamine salts) in an open-label fashion as compared to HCS. Proton spectra will be acquired from the ACC.
Detailed description
Hypothesis:
- We hypothesize that brain Glu and GABA levels and/or their ratio involved in ADHD pathology
- Glu and GABA levels and/or their ratio will be affected by medical treatment in ADHD group
- Alteration of Glu and GABA and/or their ratios, before and after treatment, will correlate with clinical response to treatment
Primary Objectives:
To characterize changes in Glu and GABA levels in the ACC of adults with ADHD compared to the healthy subjects To characterize Glu and GABA levels in the ACC of adults with ADHD before and 1.5 hrs. after stimulant treatment using 1H MRS system.
Secondary objective:
To study the correlation between Glu and GABA levels in ADHD patients (before and after medical treatment) and clinical symptoms as assessed by ASRS and DSMV and/or NeuroTrax Braincare computerized test
Design and study population:
This is a prospective observational, open-label, comparative study that is approved by the Institutional Review Board (IRB) of Maccabi Healthcare services and the Ethical Committee of Tel Aviv University, in collaboration with the Weizmann Institute of Science. Medically healthy ADHD adults of ages 18-40 years (N= 35), and matched HCS (N= 25) will be recruited.
Procedure ADHD Participants will be enrolled from the Maccabi database. Volunteers will be enrolled as a Control group
- Pre-assessment questionnaires including epidemiologic data, DSMV, and Adult ADHD Self-Report Scale (ASRS) will be filled out.
- Detailed explanation will be given of the trial objectives, trial methods and risks or possible discomfort that may result from an MRI/MRS examination
- During screening, subjects will receive information regarding the study, including general eligibility criteria, study design, procedures and duration. Subjects will have the opportunity to ask questions and will undergo an informed consent procedure. Subjects meeting inclusion/exclusion criteria will be enrolled. The participant will sign an informed consent form and will receive a copy.
After screening, participants who meet the inclusion criteria will be invited to the center for Computational Neuroimaging at Weizmann Institute of Science to perform the MRS scan.
ADHD patients will be instructed not to take medication for at least 72 hours prior to their arrival and will be asked to bring their medical drug treatment.
All participants will go through spectroscopic analyses using 1H MRS (at 3 Tesla) Control group participants will go through MRS once and complete their study. Adults with ADHD will repeat MRS screening, 1.5 hours after taking their medical treatment (Methylphenidate /Mixed Amphetamine salts).
Study population:
Medically healthy adults diagnosed with ADHD (men and women) ages 18-40 years (N= 35), treated with Amphetamines (Mixed Amphetamine salts (Attent) or short-acting methylphenidate (Ritalin)) will be enrolled from the Maccabi database. Matched HCS (N= 25) volunteers ages 18-40 years, who did not report ADHD or any other illness or medical conditions, and who do not take chronic medications, will be enrolled from the general population.
The Adult ADHD Self-Report Scale and DSMV questionnaire will be used to determine ADHD symptoms in both groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1 control healthy people Group 2 ADHD
| Arm | Type | Receives |
|---|---|---|
| Medically healthy adults diagnosed with ADHD | Active comparator | Other: Neurotransmitters evaluation by MRSMedically healthy adults diagnosed with ADHD (men and women) ages 18-40 years (N= 35), treated with Amphetamines (Mixed Amphetamine salts (Attent) or short-acting methylphenidate (Ritalin) |
| Control | No intervention | –HCS (N= 25) volunteers ages 18-40 years, who did not report ADHD or any other illness or medical conditions, and who do not take chronically medications, will be enrolled from the general population. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Giving informed written consent to participate on a voluntary basis.
- Men and women aged 18-40 years, who did not report ADHD or any other chronic or psychiatric illness or medical conditions (at most two symptoms of inattention and/or hyperactivity/impulsivity).
- Men and women aged 18-40 years, who have a diagnosis of ADHD, according to DSM V criteria by a Neurologist.
- Have a valid prescription for Mixed Amphetamine salts (Attent) or short-acting methylphenidate (Ritalin) for ADHD
- Withhold medication 72h prior to MRS scan.
Key exclusion criteria (12 listed)
- Subjects with metallic devices that precludemagnetic resonance imaging or any silver part that is not MRI compliant
- Current presence of any other DSM V psychiatric disorder
- Significant medical or neurological illness affecting brain function
- Subjects with any clinically significant or unstable medical conditions
- Use of any psychotropic medication, other than stimulants, in the previous 3 months
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 |
|---|---|---|
| Neurotransmitters evaluation by MRSBaseline MRS screening for volunteers and ADHD groups and repeated measurement for ADHD group after taking stimulant drug treatment | Other | Medically healthy adults diagnosed with ADHD |
Primary outcome
Glu and GABA levels measured by MRS in ACC brain area
Time frame: 72 hours without stimulant
Differences in levels of Glu and GABA in ADHD patients compared to healthy volunteers
Glu and GABA levels measured by MRS in ACC brain area before and after medical treatment
Time frame: 90 minutes after stimulant
Differences in levels of Glu and GABA measured before and after medical treatment.
1 secondary outcome
Correlation of Glu and GABA levels with clinical symptoms before and after stimulants
Time frame: 210 minutes after stimulant
Results and safety
The study was stopped early (reason given: Professor Assaf Tal left Weizmann Institute). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 25712432Naaijen J, Lythgoe DJ, Amiri H, Buitelaar JK, Glennon JC. Fronto-striatal glutamatergic compounds in compulsive and impulsive syndromes: a review of magnetic resonance spectroscopy studies. Neurosci Biobehav Rev. 2015 May;52:74-88. doi: 10.1016/j.neubiorev.2015.02.009. Epub 2015 Feb 21.
- Background: PubMed 24643164Maltezos S, Horder J, Coghlan S, Skirrow C, O'Gorman R, Lavender TJ, Mendez MA, Mehta M, Daly E, Xenitidis K, Paliokosta E, Spain D, Pitts M, Asherson P, Lythgoe DJ, Barker GJ, Murphy DG. Glutamate/glutamine and neuronal integrity in adults with ADHD: a proton MRS study. Transl Psychiatry. 2014 Mar 18;4(3):e373. doi: 10.1038/tp.2014.11.
- Background: PubMed 26040503Ende G, Cackowski S, Van Eijk J, Sack M, Demirakca T, Kleindienst N, Bohus M, Sobanski E, Krause-Utz A, Schmahl C. Impulsivity and Aggression in Female BPD and ADHD Patients: Association with ACC Glutamate and GABA Concentrations. Neuropsychopharmacology. 2016 Jan;41(2):410-8. doi: 10.1038/npp.2015.153. Epub 2015 Jun 4.
- Background: PubMed 27973969Bauer J, Werner A, Kohl W, Kugel H, Shushakova A, Pedersen A, Ohrmann P. Hyperactivity and impulsivity in adult attention-deficit/hyperactivity disorder is related to glutamatergic dysfunction in the anterior cingulate cortex. World J Biol Psychiatry. 2018 Oct;19(7):538-546. doi: 10.1080/15622975.2016.1262060. Epub 2016 Dec 15.
- Background: PubMed 17303167Perlov E, Philipsen A, Hesslinger B, Buechert M, Ahrendts J, Feige B, Bubl E, Hennig J, Ebert D, Tebartz van Elst L. Reduced cingulate glutamate/glutamine-to-creatine ratios in adult patients with attention deficit/hyperactivity disorder -- a magnet resonance spectroscopy study. J Psychiatr Res. 2007 Dec;41(11):934-41. doi: 10.1016/j.jpsychires.2006.12.007. Epub 2007 Feb 15.
- Background: PubMed 26441572Endres D, Perlov E, Maier S, Feige B, Nickel K, Goll P, Bubl E, Lange T, Glauche V, Graf E, Ebert D, Sobanski E, Philipsen A, Tebartz van Elst L. Normal Neurochemistry in the Prefrontal and Cerebellar Brain of Adults with Attention-Deficit Hyperactivity Disorder. Front Behav Neurosci. 2015 Sep 28;9:242. doi: 10.3389/fnbeh.2015.00242. eCollection 2015.
- Background: PubMed 30201464Bezalel V, Paz R, Tal A. Inhibitory and excitatory mechanisms in the human cingulate-cortex support reinforcement learning: A functional Proton Magnetic Resonance Spectroscopy study. Neuroimage. 2019 Jan 1;184:25-35. doi: 10.1016/j.neuroimage.2018.09.016. Epub 2018 Sep 7.
- Individual participant dataSharing planned: Yes. Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We would wish to make our results available both to the community of scientists interested in ADHD and the biology to avoid unintentional duplication of research. Conversely, we would welcome collaboration with others who could make use of the H-MRS protocols developed in psychiatric disease. Any patient-level data that is shared will be anonymized to protect personally identifiable information.
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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.
Assaf Tal, PhD. study chair
Maccabi Healthcare Services, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurotransmitters evaluation by MRS in people with Attention Deficit Disorder With Hyperactivity, run by Weizmann Institute of Science at 2 sites in Israel.
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 7 inclusion and 12 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 15 Jul 2024. 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 Israel. 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: Professor Assaf Tal left Weizmann Institute). 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?
Glu and GABA levels measured by MRS in ACC brain area (time frame: 72 hours without stimulant). 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?
On the ClinicalTrials.gov record for NCT04823364, which also lists 7 linked publications.
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 15 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.