A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults With Major Depressive Disorder, With or Without Anxious Distress

Seaport Therapeutics

Summary

This is an open-label, monotherapy, extension study to evaluate the safety and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

Eligibility

Age range: 18–66 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participant who completed treatment in Study SPT-300-2024-203 (i.e., participant who competed Visit 8 \[Day 42\] of Study SPT-300-2024-203 \[BUOY-1 Study\]). * Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP must agree to use a highly effective form of contraception during participation in the study and for 30 days after receiving the last dose of study treatment. * Participant is willing and able to refrain from the use of drugs of abuse. Exclusion Criteria: * Participants who,…

Locations (42)

Seaport Investigator Site
Chino, California
Seaport Investigator Site
Garden Grove, California
Seaport Investigator Site
Glendale, California
Seaport Investigator Site
San Jose, California
Seaport Investigator Site
Cromwell, Connecticut
Seaport Investigator Site
Lauderhill, Florida

Summary

Eligibility

Interventions

Locations (42)