NCT04148612

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: ElMindA Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2020-10-06
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2019-11-01
• Last updated: 2021-02-16

Locations

2 sites across 2 countries: Israel, Switzerland