Relmada Study

Primary objective: To evaluate the therapeutic efficacy of REL-1017 (Esmethadone HCL) as an adjunctive (302, 310)/mono (303, 310) treatment of major depressive disorder.

REL-1017-302: Adjunctive treatment with other antidepressants
REL-1017-303: Monotherapy
REL-1017-310: Open label study. Can be adjunctive or monotherapy

Main inclusion criteria:

• Age 18 – 65
• BMI: 18 – 30 (REL-310 accepts BMI up to 35)
• MDD diagnosis

Main exclusion criteria:

• Cardiac abnormalities
• Poorly controlled DM II
• Recent use of (Opioids, benzodiazepines, ketamine, heavy alcohol)
• New onset psychotherapy
• ECT, VNS or recent TMS
• Other psychiatric disorders: e.g., BP I or II, Schizophrenia
• Participated in a recent trial or multiple trials

Contact: 713-486-2623