Depression
Subjects must be diagnosed with Major Depression
The study will screen approximately 652 MDD subjects to randomize approximately 300 subjects
Inclusion Criteria
1. Signed Written Informed Consent
a. Subject must be able to understand nature of tril, foll9w protocol requirements, provide informed cos3nt, and participate in required study assessment, as determined by the Investigator.
2. Subjects must agree
To provide all demographic information (i.e.sex, at birth race, ethnicity),
3. Subjects must be able to read and
Understand language spoken at study center.
4. Written authorization for use and release
Of health and research study information has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
5. Subjects with a history of treatment
Must authorize release of medical records for confirmation of clinical history.
6. Subjects must provide
Verified Clinical Trials (VCT) authorization to confirm eligibility status (Section 4.3.1.1.)
Revolutionizing Medical Research
7. Target Population
a. Male and female subjects 18 years to 75 years of age at time of cosent.
b. Body Mass Index (BMI) must be_>18 kg/m and _<35 kg/m
c. Body weight of _> 40 kg at the screening visit
d. Meets Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for MDD, as confirmed by Mini -International Neuropsychiatric Interview (MINI) Interview with a history of at least one previous major depressive episodes (MDE).
e. Current MDE duration ->2 months and <24 months at the time of Screening