Clareo Health | An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study)
An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Seaport Therapeutics
With
Premier Research
Age
18–66
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study.
Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study (BUOY-1 Study).
Female participants with a positive urine pregnancy test result. Female participants may be enrolled without a negative urine test if they are surgically sterile or at least 2 years post-menopause.
