Depressive Disorder, MajorNCT04148612
A Study to Evaluate the Benefit of Opti-Me Application to Different Treatments of MDD
A study testing Opti-Me in people with Depressive Disorder, Major, run by ElMindA Ltd at 2 sites in 2 countries.
Trial summary
Major depressive disorder (MDD) is a debilitating disease characterized by depressed mood, diminished interests, impaired cognitive function and vegetative symptoms, such as disturbed sleep or appetite. MDD affects one in six adults in their lifetime. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Opti-Me
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Oct 2020to Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a clinical diagnosis of Major Depressive Disorder (MDD) as defined by the DSM V
- MDD Patients who in the judgement of their physician require treatment management, and are eligible to receive any of the approved SSRI/SNRI drugs defined in the study protocol or TMS treatment .
- Males and Females 18-65 years old, inclusive, at the Screening visit.
- A score of ≥ 20 on the MADRS.
- History of up to 5 failed MDD pharmacotherapies treatments within the current episode
- Patients able to understand and sign written informed consent.
- Patients able and willing to comply with the requirements of the protocol.
- Female subjects of childbearing potential who are using acceptable birth control measures.
Who cannot join
- History or presence of epilepsy or seizures or convulsions.
- History of any progressive neurological disorders in the past five ( 5 ) years.
- A suicidal attempt within the past year, score 5 on MADRS Item 10 (Suicidal Thoughts) according to investigator judgment based on interview or the C-SSRS questionnaire.
- Any clinically significant uncontrolled nervous system, gastrointestinal (GI), renal, pulmonary, cardiovascular, or hepatic concomitant disease that in the investigator's opinion would preclude patient participation.
- Diagnosis of a psychotic disorder.
- History of or current open head trauma.
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- Metal, shrapnel or other similar objects in the head that could affect the EEG. History of craniotomy, cerebral metastases, cerebrovascular accident;
- Current diagnosis of schizophrenia, schizo affective disorder, dementia, mental retardation, or major depression with psychotic features;
- Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
- Participation in any other therapeutic drug study within 60 days preceding inclusion.
- Deafness, and/or blindness.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Israel1 site, 1 recruiting
- Recruiting
Beer Ya'aqov
Be’er Ya‘aqov
Kfir Oved, kfir.oved@moh.health.gov.il
Elina Pushkarski, elina.pushkarski@MOH.HEALTH.GOV.IL
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich Hospital
Zurich
Anna Bankwitz, anna.bankwitz@pukzh.ch
Christoph Hoermann, christoph.hoermann@pukzh.ch
About this study
Official title: Study to Evaluate the Benefit of the Opti-Me Application to Inform SSRIs, SNRIs Medication Prescription or TMS Treatment for Subjects With a Primary Diagnosis of Major Depression Disorder (MDD)
Major depressive disorder (MDD) is a debilitating disease characterized by depressed mood, diminished interests, impaired cognitive function and vegetative symptoms, such as disturbed sleep or appetite. MDD affects one in six adults in their lifetime. To date, decisions regarding specific treatment protocols for MDD are based on clinical experience and risk factors with limited data on outcome prediction. In addition, since it takes 8 weeks to assess if a treatment is successful, the long and often unsuccessful search for an effective antidepressant is accompanied by significant decrease in patients' quality of life, an increased risk of suicidal action, and decreased chance of response and remission with each attempt. This has led to examination of various markers (e.g., neuroimaging, electrophysiological, genetic and behavioral) in an attempt to predict the response to various forms of treatments, including pharmacotherapies and TMS (Transcranial Magnetic Stimulation) for depression.
Elminda had developed a novel, non-invasive imaging EEG-based technology, Brain Network Analytics (BNA), for visualization and quantification of specific brain functions. The rationale of the study is to develop a reliable marker for MDD treatment outcome based on the BNA.
Read the detailed description
Elminda was granted a specific funding from the European Union in the framework of the Horizon 2020 program (Grant No: 808677 \& 859051) to perform this study.
- Conditions
- Depressive Disorder, Major
- Being tested
- Opti-Me
- 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.
Opti-MeDiagnostic test
Opti-Me algorithm provides the likelihood of response to the 3 treatment options: SSRIs, SNRIs or TMS in MDD patients.
| Study group | Role | What they receive |
|---|---|---|
| Opti-Me | Experimental | Patients in this group will be treated based on the Opti-Me algorithm recommended treatment. Receives: Diagnostic Test: Opti-Me |
| Randomization | No intervention | Patients in this group will be treated by random assignment of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response to treatment based on the Montgomery-Asberg Depression Rating Scale (MADRS) defined as a decline of at least 50% in the MADRS score from Baseline (BL) to the end of treatment (EOT) period which will be defined per treatment type.
Measured: up to 8 weeks
Accuracy of the model will be assessed by the specificity and sensitivity of the model developed based on Cohort 1(GR1) and implemented in Cohort 2 Arm A (GR2A).
Measured: end of study, estimated 2 years
Comparison of the proportion of responders in Cohort 2 Arm A (GR2A) (assignment to treatment with the guidance of the Opti-Me algorithm) vs Cohort 1 (GR1) + Cohort 2 Arm B (GR2B) (random allocation to treatment).
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start6 Oct 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148612
- Sponsor's protocol ID
- ELM-56
- Status last verified
- Feb 2021
- First submitted
- 29 Oct 2019
- Last updated
- 16 Feb 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 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Benefit of the Opti-Me Application to Inform SSRIs, SNRIs Medication Prescription or TMS Treatment for Subjects With a Primary Diagnosis of Major Depression Disorder (MDD)
- ClinicalTrials.gov ID
- NCT04148612
- Acronym / sponsor ID
- ELM-56
- Conditions
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 1 Nov 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.
Major depressive disorder (MDD) is a debilitating disease characterized by depressed mood, diminished interests, impaired cognitive function and vegetative symptoms, such as disturbed sleep or appetite. MDD affects one in six adults in their lifetime. To date, decisions regarding specific treatment protocols for MDD are based on clinical experience and risk factors with limited data on outcome prediction. In addition, since it takes 8 weeks to assess if a treatment is successful, the long and often unsuccessful search for an effective antidepressant is accompanied by significant decrease in patients' quality of life, an increased risk of suicidal action, and decreased chance of response and remission with each attempt. This has led to examination of various markers (e.g., neuroimaging, electrophysiological, genetic and behavioral) in an attempt to predict the response to various forms of treatments, including pharmacotherapies and TMS (Transcranial Magnetic Stimulation) for depression.
Elminda had developed a novel, non-invasive imaging EEG-based technology, Brain Network Analytics (BNA), for visualization and quantification of specific brain functions. The rationale of the study is to develop a reliable marker for MDD treatment outcome based on the BNA.
Detailed description
Elminda was granted a specific funding from the European Union in the framework of the Horizon 2020 program (Grant No: 808677 \& 859051) to perform this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opti-Me | Experimental | Diagnostic Test: Opti-MePatients in this group will be treated based on the Opti-Me algorithm recommended treatment. |
| Randomization | No intervention | –Patients in this group will be treated by random assignment of treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a clinical diagnosis of Major Depressive Disorder (MDD) as defined by the DSM V
- MDD Patients who in the judgement of their physician require treatment management, and are eligible to receive any of the approved SSRI/SNRI drugs defined in the study protocol or TMS treatment .
- Males and Females 18-65 years old, inclusive, at the Screening visit.
- A score of ≥ 20 on the MADRS.
- History of up to 5 failed MDD pharmacotherapies treatments within the current episode
Key exclusion criteria (11 listed)
- History or presence of epilepsy or seizures or convulsions.
- History of any progressive neurological disorders in the past five ( 5 ) years.
- A suicidal attempt within the past year, score 5 on MADRS Item 10 (Suicidal Thoughts) according to investigator judgment based on interview or the C-SSRS questionnaire.
- Any clinically significant uncontrolled nervous system, gastrointestinal (GI), renal, pulmonary, cardiovascular, or hepatic concomitant disease that in the investigator's opinion would preclude patient participation.
- Diagnosis of a psychotic disorder.
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 |
|---|---|---|
| Opti-MeOpti-Me algorithm provides the likelihood of response to the 3 treatment options: SSRIs, SNRIs or TMS in MDD patients. | Diagnostic test | Opti-Me |
Primary outcome
The response to treatment based on the Montgomery-Asberg Depression Rating Scale (MADRS) defined as a decline of at least 50% in the MADRS score from Baseline (BL) to the end of treatment (EOT) period which will be defined per treatment type.
Time frame: up to 8 weeks
Accuracy of the model will be assessed by the specificity and sensitivity of the model developed based on Cohort 1(GR1) and implemented in Cohort 2 Arm A (GR2A).
Time frame: end of study, estimated 2 years
Comparison of the proportion of responders in Cohort 2 Arm A (GR2A) (assignment to treatment with the guidance of the Opti-Me algorithm) vs Cohort 1 (GR1) + Cohort 2 Arm B (GR2B) (random allocation to treatment).
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opti-Me in people with Depressive Disorder, Major, run by ElMindA Ltd at 2 sites in 2 countries.
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 8 inclusion and 11 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 16 Feb 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 Israel, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liran Korine (+972-9-9516476, liran@elminda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response to treatment based on the Montgomery-Asberg Depression Rating Scale (MADRS) defined as a decline of at least 50% in the MADRS score from Baseline (BL) to the end of treatment (EOT) period which will be defined per treatment type. (time frame: up to 8 weeks). The study lists 3 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 16 Feb 2021.