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

Primary Purpose

Depressive Disorder, Major

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Opti-Me

About this trial

This is an interventional supportive care trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.
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.

Sites / Locations

Beer Ya'aqovRecruiting
University of Zurich HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Opti-Me

Randomization

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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).

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 Outcome Measures

Full Information

NCT ID

NCT04148612

First Posted

October 29, 2019

Last Updated

February 15, 2021

Sponsor

ElMindA Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04148612

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 6, 2020 (Actual)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ElMindA Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Opti-Me

Arm Type

Experimental

Arm Description

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

Arm Title

Randomization

Arm Type

No Intervention

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Opti-Me

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

up to 8 weeks

Title

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

Title

Time Frame

up to 8 weeks

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

The study population will consist of at least 40% Male and 40% Female patients

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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. Key Exclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liran Korine

Phone

+972-9-9516476

liran@elminda.com

Facility Information:

Facility Name

Beer Ya'aqov

City

Be'er Ya'aqov

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kfir Oved

kfir.oved@moh.health.gov.il

First Name & Middle Initial & Last Name & Degree

Elina Pushkarski

elina.pushkarski@MOH.HEALTH.GOV.IL

First Name & Middle Initial & Last Name & Degree

Eiran Harel, MD

Facility Name

University of Zurich Hospital

City

Zürich

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Bankwitz

anna.bankwitz@pukzh.ch

First Name & Middle Initial & Last Name & Degree

Christoph Hoermann

christoph.hoermann@pukzh.ch

First Name & Middle Initial & Last Name & Degree

Sebastian Olbrich, MD

12. IPD Sharing Statement

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

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