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

NCT ID: NCT04148612

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2022-01-31

Brief 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. 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.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Opti-Me

Patients in this group will be treated based on the Opti-Me algorithm recommended treatment.

Group Type: EXPERIMENTAL

Opti-Me

Intervention Type: DIAGNOSTIC_TEST

Opti-Me algorithm provides the likelihood of response to the 3 treatment options: SSRIs, SNRIs or TMS in MDD patients.

Randomization

Patients in this group will be treated by random assignment of treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Opti-Me

Opti-Me algorithm provides the likelihood of response to the 3 treatment options: SSRIs, SNRIs or TMS in MDD patients.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ElMindA Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beer Ya'aqov

Be’er Ya‘aqov, , Israel

Site Status: RECRUITING

University of Zurich Hospital

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Israel; Switzerland

Central Contacts

Liran Korine

Role: CONTACT

liran@elminda.com

+972-9-9516476

Facility Contacts

Kfir Oved

Role: primary

kfir.oved@moh.health.gov.il

Elina Pushkarski

Role: backup

elina.pushkarski@MOH.HEALTH.GOV.IL

Anna Bankwitz

Role: primary

anna.bankwitz@pukzh.ch

Christoph Hoermann

Role: backup

christoph.hoermann@pukzh.ch

Other Identifiers

ELM-56

Identifier Type: -

Identifier Source: org_study_id