BREXANOLONE CAPRILCERBATE for Major depressive disorder

Inclusion criteria

• {"criterion_text":"- Participant who completed treatment in Study SPT-300-2024-203-OUS (ie, participant who competed Visit 6 [Day 42] of Study SPT-300-2024-203-OUS)\n- Participant must be able, willing, and have capacity to provide written informed consent prior to any study procedures and should agree to comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.\n- 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 at least an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment.\n- Male participants and their female partners should agree to use at least an acceptable method of effective contraception for the duration of study and for at least 30 days after receiving the last dose of the study treatment.\n- Participant is willing and able to refrain from the use of drugs of abuse (including recreational cannabinoids/medical cannabinoids) and alcohol for the duration of the study.\n- Willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures and requirements."}

Exclusion criteria

• {"criterion_text":"- Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study.\n- Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study.\n- 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."}

Primary endpoints

• {"endpoint_text":"- Incidence, severity, and duration of treatment-emergent adverse events, serious adverse events, and incidence of clinically significant vital signs, electrocardiograms, safety laboratory, and physical examination findings","definition_or_measurement_approach":"Collection and reporting of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); monitoring and recording of vital signs, electrocardiograms (ECGs), safety laboratory tests and physical examination findings to assess incidence, severity and duration."}
• {"endpoint_text":"- Suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale","definition_or_measurement_approach":"Assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)."}

Secondary endpoints

• {"endpoint_text":"- Change from Baseline to Visit 6 (Study Day 42) in the following: •\tHAM-D-17 total score •\tCGI-S •\tHamilton Anxiety Rating Scale •\tPGI-S •\tSheehan Disability Scale •\tThe Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form","definition_or_measurement_approach":"Change from baseline to Visit 6 (Day 42) measured by HAM-D-17 total score, CGI-S, Hamilton Anxiety Rating Scale (HAM-A), PGI-S, Sheehan Disability Scale (SDS), and Q-LES-Q-SF."}

Methods

• GP letters: country-specific GP letters (documents titled K2_Recruitment materials_GP Letter in multiple country variants) to engage primary care/GPs.
• Participant handouts and printed recruitment materials (EMA Wellness participant handout, general EMA Wellness content) provided to potential participants.
• Mobile app / digital eCOA: a validated eCOA smartphone application (dosing reminders) and EMA Wellness mobile app screenshots are included in recruitment materials.
• Mobile and digital content available in multiple languages (documents show ENG, ROM, CZE, HUN, BUL, SVK, DEU variants).
• Patient support (logistics): patient travel reimbursement and transport services provided by Block Clinical Inc. to support participation.

Poland

Earliest CTIS Part Ii Submission Date

24-10-2025

Latest Decision Or Authorization Date

13-11-2025

Processing Time Days

20

Number Of Sites

13

Number Of Participants

87

Hungary

Earliest CTIS Part Ii Submission Date

20-10-2025

Latest Decision Or Authorization Date

10-11-2025

Processing Time Days

21

Number Of Sites

4

Number Of Participants

20

Romania

Earliest CTIS Part Ii Submission Date

22-10-2025

Latest Decision Or Authorization Date

11-11-2025

Processing Time Days

20

Number Of Sites

1

Number Of Participants

20

Slovakia

Earliest CTIS Part Ii Submission Date

31-07-2025

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

207

Number Of Sites

3

Number Of Participants

23

Germany

Earliest CTIS Part Ii Submission Date

16-09-2025

Latest Decision Or Authorization Date

04-12-2025

Processing Time Days

79

Number Of Sites

4

Number Of Participants

22

Bulgaria

Earliest CTIS Part Ii Submission Date

24-10-2025

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

186

Number Of Sites

4

Number Of Participants

33

Czechia

Earliest CTIS Part Ii Submission Date

22-10-2025

Latest Decision Or Authorization Date

26-02-2026

Processing Time Days

127

Number Of Sites

6

Number Of Participants

45

Primary sponsor

Full Name

Seaport Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Block Clinical Inc.

Responsibilities

Patient travel reimbursement, transport service

Name

Premier Research Group S.L.

Name

Medidata Solutions Inc.

Third parties

• {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"Completes packaging/labeling for US/EU release","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Block Clinical Inc.","duties_or_roles":"Patient travel reimbursement, transport service","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Medical imaging - ECG","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"YES Print","duties_or_roles":"Printing services","organisation_type":"SME"}
• {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"EU release and distribution","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Etymax Limited","duties_or_roles":"Translation services","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Premier Research Group S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"Rater Training","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"EMA Wellness LLC","duties_or_roles":"a validated eCOA smart phone application (dosing reminders)","organisation_type":"Non-Pharmaceutical company"}