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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study to Evaluate the Benefit of Opti-Me Application to Different Treatments of MDD
