Opti-Me Solution

About

Depression has been identified as the leading and most costly mental disorder, accounting for 33% of the total cost of brain disorders. Each year, about 7% of the population suffer from depression in Europe, equivalent to 52 million people. Despite the resulting need for superior clinical treatments, depression treatment has not changed for several decades. Current treatment methods are prescribed through trial and error with patients rarely receiving the ‘right’ treatment from day one.

This is where the Opti-Me solution comes in. Opti-Me solution is a novel EEG-based screening software solution that predicts responsiveness to both anti-depressants (SSNI and SNRI) and Transcranial Magnetic Stimulation (TMS) treatment, enabling tailored and optimized treatment based on brain-related biomarkers. Similar to a BNA test, the patient’s neural networks are recorded at rest and during cognitive tasks. Once the screening process is performed, advanced algorithmic analysis methods transform the cognitive and electrophysiological data into clinically meaningful insights which compiled in the Opti-Me report.

The Opti-Me report is presented to clinicians in a format similar to antibiotic sensitivity testing and includes different levels of information, including the patient’s likelihood to respond to a specific treatment, ongoing EEG analysis, and behavioral data in order to orient the optimal anti-depressant treatment.

The Opti-Me solution is expected to dramatically reduce time from diagnosis to amelioration of symptoms, thereby reducing costs, reducing suicide attempts, and increasing quality of life for depression patients.

The Opti-Me Project (previously called Predict)

Opti-Me project ultimate objective is to advance the Opti-Me solution to commercialisation in Europe. This entails a number of technical and strategic objectives, including the optimisation of the Opti-Me algorithm and procedure, IP portfolio management, clinical validation study, and the exploitation of results through effective dissemination. The clinical data will also be used for the CE Marking of the Opti-Me solution and first reimbursement requests.

To this end, the project will be executed over 24 months with activities broken down into 5 Work Packages:

  1. Final optimisation and scale-up of the system including the incorporation of additional neuromarkers and Opti-Me test optimisation. This will be performed in 2 stages – the first stage will be based on previous clinical trials results and the second stage will be following the results from the large-scale clinical trial within the project.
  2. Preparation for the clinical validation e.g. document submissions and patient enrolment.
  3. Clinical trial execution with 390 patients in at least 5 leading clinical centers (Israel, Germany, Switzerland, and Italy), analysis of results collected, CE mark application and initial reimbursement applications.
  4. Exploitation and communication of project results
  5. Project management.

The Opti-Me Team

The Opti-Me project’s multi-disciplinary team includes accomplished neuroscientists, SW engineers, IP and regulatory experts, and business and operations professionals.

Clinical Study Status

We are currently in the start-up stage of the study in which regulatory submissions are taking place in parallel to other administrative tasks. First ethical committee approvals have been already received in the following sites:

  • The Clinical Center for Mental Health Be’er Yaakov-Ness Ziona, Israel (PI: Dr. Eiran Harel)
  • The Jerusalem Center for Mental Health, Israel (PI: Dr. Renana Eitan)
  • The University of Zurich, Switzerland (PI: Dr. Sebastian Olbrich)

Patients recruitment was delayed due to the current COVID-19 crisis but is expected to begin by June 2020 with the aim to enroll up to 390 MDD patients.

The Predict project has received funding from the European Union’s research and Innovation programme under grant agreements No: 808677 & 859051

Contact Us

If you have any questions regarding this exciting project, the best way to reach our team is at predictsolution@elminda.com.                                                                                                                                                                                                                                                                                                                                                                                                                             

The Opti-Me Clinical Study, in depth

A Multi-Center 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)

Purpose

This is a clinical study for the development of a reliable marker for MDD treatment outcome based on Brain Network Analytics (BNA). For that purpose, BNA data will be collected during psychiatric clinical practice in a non-invasive manner and will be used to develop the Opti-Me algorithm that provides the likelihood of response for the 3 treatment options, including SSRIs, SNRIs or TMS.

The study key objectives are twofold. First, to validate current algorithms and enhance and calibrate the Opti-Me models. Second, to evaluate the Opti-Me algorithm accuracy in predicting responses to different treatment options, including SSRIs, SNRIs, and TMS.

​​Study Cohorts and Arms:

Cohort 1 (GR1): Random treatment assignment (1:1:1 ratio to SSRI, SNRI or TMS)

Cohort 2 (GR2): Random assignment to one of two arms (i.e., Arm A or B) in a 4:1 ratio:

– Arm A: Opti-Me algorithm treatment assignment

– Arm B: Random treatment assignment (1:1:1 ratio to SSRIs, SNRIs or TMS)

In both cohorts, patients will be stratified according to the historical number of failed MDD pharmacotherapies (0 or 1-2, or 3-5) within the current episode with at least one of the study-approved drugs. A patient who had previously failed MDD treatment will be defined as a patient who received an MDD pharmacotherapy treatment for a clinically meaningful duration and dose. A patient who failed MDD pharmacotherapy treatment may also be defined as treatment discontinued due to an AE.

Primary Endpoint

The response to treatment based on the MADRS defined as a decline of at least 50% in the MADRS score from Baseline (BL) to the End of Treatment (EOT) which will be defined per treatment type.

Accuracy of the model will be assessed by the specificity and sensitivity in predicting response in Cohort 2 Arm A (GR2A) and using the model developed based on Cohort 1(GR1) and implemented in Cohort 2 Arm A (GR2A).

Benefit of the treatment allocation by the Opti-Me algorithm, will be assessed by 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).

Secondary Endpoints

  1. Remission defined as MADRS ≤10 at the End of Treatment (EOT) visit.
  2. Percent change from Baseline to EOT based on the MADRS.
  3. Discontinuation rates based on occurrence of dropouts.
  4. Change in Quality of Life based on the WHO quality of life QOL (WHOQoL) scale from Baseline to EOT.
  5. Percent change from Baseline to EOT based on the Quick Inventory of Depressive Symptomatology- Self-Report 16 (QIDS-SR-16).
  6. Change in depression and anxiety from Baseline to EOT based on the Depression, Anxiety and Stress Scale (DASS-21).
  7. Change in patient’s satisfaction from Baseline to EOT based on the Short Assessment of Patient Satisfaction (SAPS) questionnaire.
  8. Change in patient’s disability from Baseline to EOT based on Sheehan Disability Scale (SDS).
  9. Change in executive cognitive function from Baseline to EOT based on the Digit Symbol Substitution Test (DSST).
  10. Change in illness severity from Baseline to EOT based on the Clinical Global Impression Severity (CGI-S) scale.

Exploratory Endpoints

  1. Evaluation of total cost of care based on the Work Productivity and Activity Impairment (WPAI).
  2. Additional exploratory endpoints will be defined in the SAP based on the applicability of additional models.

Study Population

The study population will consist of at least 40% Male and 40% Female patients, ages 18-65, diagnosed with MDD and currently in an acute depressive episode, who in the opinion of their physician, require treatment and are eligible to receive any of the approved SSRI/SNRI drugs defined in the study protocol, undergo TMS treatment, and comply with the inclusion/exclusion criteria.

Inclusion Criteria:

  1. Patients with a clinical diagnosis of Major Depressive Disorder (MDD) as defined by the DSM V
  2. 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 .
  3. Males and Females 18-65 years old, inclusive, at the Screening visit.
  4. A score of ≥ 20 on the MADRS.
  5. History of up to 5 failed MDD pharmacotherapies treatments within the current episode
  6. Patients able to understand and sign written informed consent.
  7. Patients able and willing to comply with the requirements of the protocol.
  8. Female subjects of childbearing potential who are using acceptable birth control measures.

Exclusion Criteria:

  1. History or presence of epilepsy or seizures or convulsions.
  2. History of any progressive neurological disorders in the past five ( 5 ) years.
  3. 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.
  4. 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.
  5. Diagnosis of a psychotic disorder.
  6. History of or current open head trauma.
  7. Metal, shrapnel or other similar objects in the head that could affect the EEG. History of craniotomy, cerebral metastases, cerebrovascular accident;
  8. Current diagnosis of schizophrenia, schizo affective disorder, dementia, mental retardation, or major depression with psychotic features;
  9. Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
  10. Participation in any other therapeutic drug study within 60 days preceding inclusion.
  11. Deafness, and/or blindness.

ClinicalTrials.gov Identifier

NCT04148612 – A Study to Evaluate the Benefit of Opti-Me Application to Different Treatments of MDD.

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