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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)

NCT07161700

Enrolling By InvitationPhase 2

Sponsor: Seaport Therapeutics

Conditions: Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress

Interventions: SPT-300

Countries: United States, Bulgaria, Czechia, Germany, Hungary, Poland, Slovakia

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 overview

Sex: ALL

Age: 18 Years to 66 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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, 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.
Locations (40)
  • Chino, California, United States
  • Garden Grove, California, United States
  • Glendale, California, United States
  • San Jose, California, United States
  • Cromwell, Connecticut, United States
  • Lauderhill, Florida, United States
  • Palm Bay, Florida, United States
  • West Palm Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Brooklyn, New York, United States
  • Cedarhurst, New York, United States
  • New York, New York, United States
  • Staten Island, New York, United States
  • Independence, Ohio, United States
  • North Canton, Ohio, United States
  • Irving, Texas, United States
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Brno, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Berlin, Brandenburg, Germany
  • Schwerin, Mecklenburg-Vorpommern, Germany
  • Chemnitz, Germany
  • Budapest, Hungary
  • + 10 more on CT.gov