Major DepressionNCT03670823
Prediction of SSRI Treatment in Major Depression.
An observational study of Major Depression, run by ElMindA Ltd at 1 site in Israel.
Trial summary
This project will combine the data collected from EEG, Eye tracking, structural and functional MRI scans and neuropsychological performance from patients with major depression receiving SSRI treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- SIEMENS PRISMA MRI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to 1 Oct 2020
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will include 2 groups of subjects: healthy subjects and patients with major depression
Who may be able to join
- Patients 18-65 years old
- Male and female
- Ability to comprehend and sign informed consent
- DSM-5 diagnosis with MINI 7.0.2 (healthy subjects need to be ruled out)
- DSM-5 diagnosis
- 0-2 failed treatments
- Patients which will start SSRI treatment
Who cannot join
- unconsciousness
- Pregnancy or nursing
- Cardiovascular instability
- Metabolic instability (water, electrolytes, sugar)
- Fever or evidence of microbiological pollutant
- Deafness or blindness
Show all 13Show fewer
- Schizophrenia
- Addiction disorders
- Eating disorders
- Bi-polar disorder
- Cognitive deficits
- Start a new psychotherapy during the research
- Unable to enter the MRI scanner
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical CENTER
Ramat Gan, 52621
Sarel Shlomo, 03-5303075, nivdakim.sheba@gmail.com
About this study
Official title: A Combination of Innovative Technologies: EEG, Eye Tracking Device and fMRI in Order to Predict the Success of SSRI Treatment in Patients With Major Depression.
This project will combine the data collected from EEG, Eye tracking, structural and functional MRI scans and neuropsychological performance from patients with major depression receiving SSRI treatment. The purpose of this research is to predict the success of the SSRI treatment and to categorize patients into sub-groups according to similar patterns of brain activation to personalize treatment.
Read the detailed description
Major depression is a mood disorder affecting 350 million people worldwide. The disorder is characterized by depressed mood, anhedonia, decreased quality of life, deficits in cognitive functions and even suicide thoughts. Treatment of depression is often a long process and includes taking different types and quantities of medications. Therefore, there is a need to predict the success of the SSRI treatment. Our research will examine the outcomes of the combined technologies: BNA (EEG), Eye-tracker, structural and functional MRI scans and neuropsychology tasks in patients with depression while receiving SSRI treatment. The purpose of the research is to track biomarkers and other measures, which will allow predicting the SSRI treatment's success within 4 weeks instead of 8 weeks. In addition, the investigators will attempt to categorize patients into different subgroups according to their brain activation and eye movements. This division into subgroups may contribute to the understanding of the mechanisms that account for the responsiveness to SSRI treatment and to the possibility of targeting patients with depression towards a particular treatment. From this research, the investigators aim to personalize the treatment of depression, make it more efficient and reduce the amount of time for the patient to reach an optimal responsiveness.
- Conditions
- Major Depression
- Being tested
- SIEMENS PRISMA MRI
- Keywords
- Major Depression, EEG, Eye Tracker, fMRI, MRI, Resting State Connectivity, Cognition
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIEMENS PRISMA MRIDevice
Also called BNA (EEG) Technology, Eyetracking device
Collect data on brain activation from different methods
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | 50 healthy subjects for a control group Receives: Device: SIEMENS PRISMA MRI | |
| Patients with Major Depression | 50 patients with major depression for a research group Receives: Device: SIEMENS PRISMA MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG responses to cognitive tasks in combination with the Eye-tracker Device.
Categorize patients into subgroups according to combined measures of EEG and Eye
Measured: 2 years
Secondary outcomes (6)
Resting state connectivity analysis
Examine the difference in resting state connectivity between the groups.
Measured: 2 years
Examine correlations between the different methods
Examine correlations between the different methods EEG, Eye-tracking and fMRI
Measured: 2 years
EEG brain activation to cognitive tasks
Categorize patients into subgroups according to similar brain activity
Measured: 2 years
Eye-tracking tasks
Categorize patients into subgroups according to similar patterns of eye movements.
Measured: 2 years
Examine MRI structural changes
Compare structural changes between the groups (patients with depression, healthy subjects).
Measured: 2 years
Cognitive scores on CANTAB (computerized cognitive assessments)
Examine the difference in responses to different cognitive exams between the groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Mar 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center, Hebrew University of Jerusalem
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670823
- Sponsor's protocol ID
- ELM-55 5323-18-SMC
- Status last verified
- May 2019
- First submitted
- 12 Sep 2018
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Drysdale AT, Grosenick L, Downar J, Dunlop K, Mansouri F, Meng Y, Fetcho RN, Zebley B, Oathes DJ, Etkin A, Schatzberg AF, Sudheimer K, Keller J, Mayberg HS, Gunning FM, Alexopoulos GS, Fox MD, Pascual-Leone A, Voss HU, Casey BJ, Dubin MJ, Liston C. Resting-state connectivity biomarkers define neurophysiological subtypes of depression. Nat Med. 2017 Jan;23(1):28-38. doi: 10.1038/nm.4246. Epub 2016 Dec 5.
PubMed 27918562Ogawa T, Sekino H, Uzura M, Sakamoto T, Taguchi Y, Yamaguchi Y, Hayashi T, Yamanaka I, Oohama N, Imaki S. Comparative study of magnetic resonance and CT scan imaging in cases of severe head injury. Acta Neurochir Suppl (Wien). 1992;55:8-10. doi: 10.1007/978-3-7091-9233-7_3.
PubMed 1414552Raichle ME, Snyder AZ. A default mode of brain function: a brief history of an evolving idea. Neuroimage. 2007 Oct 1;37(4):1083-90; discussion 1097-9. doi: 10.1016/j.neuroimage.2007.02.041. Epub 2007 Mar 6.
PubMed 17719799Rohden AI, Benchaya MC, Camargo RS, Moreira TC, Barros HMT, Ferigolo M. Dropout Prevalence and Associated Factors in Randomized Clinical Trials of Adolescents Treated for Depression: Systematic Review and Meta-analysis. Clin Ther. 2017 May;39(5):971-992.e4. doi: 10.1016/j.clinthera.2017.03.017. Epub 2017 May 2.
PubMed 28476404
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Innovative Technologies: EEG, Eye Tracking Device and fMRI in Order to Predict the Success of SSRI Treatment in Patients With Major Depression.
- ClinicalTrials.gov ID
- NCT03670823
- Acronym / sponsor ID
- ELM-55 5323-18-SMC
- Conditions
- Major Depression
- Keywords
- Major Depression, EEG, Eye Tracker, fMRI, MRI, Resting State Connectivity, Cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center, Hebrew University of Jerusalem
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 14 Sep 2018 (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 will combine the data collected from EEG, Eye tracking, structural and functional MRI scans and neuropsychological performance from patients with major depression receiving SSRI treatment. The purpose of this research is to predict the success of the SSRI treatment and to categorize patients into sub-groups according to similar patterns of brain activation to personalize treatment.
Detailed description
Major depression is a mood disorder affecting 350 million people worldwide. The disorder is characterized by depressed mood, anhedonia, decreased quality of life, deficits in cognitive functions and even suicide thoughts. Treatment of depression is often a long process and includes taking different types and quantities of medications. Therefore, there is a need to predict the success of the SSRI treatment. Our research will examine the outcomes of the combined technologies: BNA (EEG), Eye-tracker, structural and functional MRI scans and neuropsychology tasks in patients with depression while receiving SSRI treatment. The purpose of the research is to track biomarkers and other measures, which will allow predicting the SSRI treatment's success within 4 weeks instead of 8 weeks. In addition, the investigators will attempt to categorize patients into different subgroups according to their brain activation and eye movements. This division into subgroups may contribute to the understanding of the mechanisms that account for the responsiveness to SSRI treatment and to the possibility of targeting patients with depression towards a particular treatment. From this research, the investigators aim to personalize the treatment of depression, make it more efficient and reduce the amount of time for the patient to reach an optimal responsiveness.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Device: SIEMENS PRISMA MRI50 healthy subjects for a control group |
| Patients with Major Depression | – | Device: SIEMENS PRISMA MRI50 patients with major depression for a research group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include 2 groups of subjects: healthy subjects and patients with major depression
Key inclusion criteria (7 listed)
- Patients 18-65 years old
- Male and female
- Ability to comprehend and sign informed consent
- DSM-5 diagnosis with MINI 7.0.2 (healthy subjects need to be ruled out)
- DSM-5 diagnosis
Key exclusion criteria (13 listed)
- unconsciousness
- Pregnancy or nursing
- Cardiovascular instability
- Metabolic instability (water, electrolytes, sugar)
- Fever or evidence of microbiological pollutant
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 |
|---|---|---|
| SIEMENS PRISMA MRIAlso: BNA (EEG) Technology, Eyetracking deviceCollect data on brain activation from different methods | Device | Healthy subjects, Patients with Major Depression |
Primary outcome
EEG responses to cognitive tasks in combination with the Eye-tracker Device.
Time frame: 2 years
Categorize patients into subgroups according to combined measures of EEG and Eye
6 secondary outcomes
Resting state connectivity analysis
Time frame: 2 years
Examine correlations between the different methods
Time frame: 2 years
EEG brain activation to cognitive tasks
Time frame: 2 years
Eye-tracking tasks
Time frame: 2 years
Examine MRI structural changes
Time frame: 2 years
Cognitive scores on CANTAB (computerized cognitive assessments)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Background: PubMed 27918562Drysdale AT, Grosenick L, Downar J, Dunlop K, Mansouri F, Meng Y, Fetcho RN, Zebley B, Oathes DJ, Etkin A, Schatzberg AF, Sudheimer K, Keller J, Mayberg HS, Gunning FM, Alexopoulos GS, Fox MD, Pascual-Leone A, Voss HU, Casey BJ, Dubin MJ, Liston C. Resting-state connectivity biomarkers define neurophysiological subtypes of depression. Nat Med. 2017 Jan;23(1):28-38. doi: 10.1038/nm.4246. Epub 2016 Dec 5.
- Background: PubMed 1414552Ogawa T, Sekino H, Uzura M, Sakamoto T, Taguchi Y, Yamaguchi Y, Hayashi T, Yamanaka I, Oohama N, Imaki S. Comparative study of magnetic resonance and CT scan imaging in cases of severe head injury. Acta Neurochir Suppl (Wien). 1992;55:8-10. doi: 10.1007/978-3-7091-9233-7_3.
- Background: PubMed 17719799Raichle ME, Snyder AZ. A default mode of brain function: a brief history of an evolving idea. Neuroimage. 2007 Oct 1;37(4):1083-90; discussion 1097-9. doi: 10.1016/j.neuroimage.2007.02.041. Epub 2007 Mar 6.
- Background: PubMed 28476404Rohden AI, Benchaya MC, Camargo RS, Moreira TC, Barros HMT, Ferigolo M. Dropout Prevalence and Associated Factors in Randomized Clinical Trials of Adolescents Treated for Depression: Systematic Review and Meta-analysis. Clin Ther. 2017 May;39(5):971-992.e4. doi: 10.1016/j.clinthera.2017.03.017. Epub 2017 May 2.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression, run by ElMindA Ltd at 1 site 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 13 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: status not confirmed, as of the sponsor's last update on 7 Jun 2019. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Revital Amiaz (+972505250590, Revital.Amiaz@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG responses to cognitive tasks in combination with the Eye-tracker Device. (time frame: 2 years). 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 NCT03670823, which also lists 4 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 7 Jun 2019.