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

NCT04148612 | Unknown

• 1 other identifier: ELM-56
• Study Type: interventional
• Target: 390
• Locations: 2 countries
• Sites: 2

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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).

  up to 8 weeks

Study Arms (2)

Opti-Me

EXPERIMENTAL

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

Diagnostic Test: Opti-Me

Randomization

NO INTERVENTION

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

Interventions

Opti-Me DIAGNOSTIC_TEST

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

Opti-Me

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: The study population will consist of at least 40% Male and 40% Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Deafness, and/or blindness.

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (2)

Beer Ya'aqov

Be’er Ya‘aqov, Israel

RECRUITING

University of Zurich Hospital

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Liran Korine

CONTACT

+972-9-9516476; liran@elminda.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 1, 2019
• Study Start: October 6, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

IL (1); CH (1)