Depression drug trial halted early: what we know

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 21 - 60 years, male or female 2. Current diagnosis of Major Depressive Disorder (MDD) without psychotic features 3. 24-item Hamilton Rating Scale for Depression (HRSD) ≥ 16 4. At least two previous antidepressant treatment failures (adequate trials within current episode) with a SSRI, SNRI, bupropion, tricyclic antidepressant, mirtazapine, nefazodone, or monoamine oxidase inhibitor, or transcranial magnetic stimulation (TMS), or IV ketamine or nasal ketamine. 5. Capable of providing informed consent and complying with study procedures 6. Currently using or willing to use contraception, if woman of childbearing potential (such as condoms, IUD, or oral contraceptive), for duration of the study. Exclusion Criteria: 1. Any history of opioid-use disorder 2. Any history of moderate- non-opioid (except for Nicotine) substance-use disorder. 3. Any severity of alcohol use disorder (including mild) 4. Past or current psychosis, psychotic disorder (including psychotic MDD), mania, or bipolar disorder 5. Hamilton Rating Scale for Depression (HRSD) suicide item \> 2 or Clinical Global Impressions (CGI)-Severity score of 7 at baseline 6. Previous or current treatment with Tianeptine 7. Current treatment or currently taking an opioid. 8. Failed depression treatment with electroconvulsive therapy. 9. Acute, severe, or unstable medical illness 10. Weight \> 300 lbs, or girth size incompatible with scanner bore. 11. Any physical or intellectual disability adversely affecting ability to complete assessments. MMSE \<26 12. for MSSM site - Having contraindication to MRI scanning (such as metal in body) or inability to tolerate the scanning procedures (e.g., severe obesity, claustrophobia) 13. Current pregnancy or currently breast feeding. 14. Abnormal baseline liver function tests 15. Currently being treated with an antidepressant medication, an antipsychotic or mood stabilizer. a) If a participant is taking a protocol dis-allowed medication at the time of screening and despite medication treatment still meets the inclusion criteria of an HRSD\>16, the participant may discontinue the medication under the supervision of their treating physician or the study clinician. 16. Positive urine toxicity at screening (except for cannabinoid)