BREXANOLONE CAPRILCERBATE for Major depressive disorder

Inclusion criteria

• {"criterion_text":"- Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent."}
• {"criterion_text":"- Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline."}
• {"criterion_text":"- Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening."}

Exclusion criteria

• {"criterion_text":"- History of, or current presentation consistent with: a.\tany depressive episode with psychotic or catatonic features b.\tany bipolar manic, hypomanic or mixed episode, and substance-induced (eg, antidepressant-induced) manic, hypomanic/mixed episode c.\tbipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression d.\tschizophrenia, schizoaffective, or other psychotic disorder e.\tobsessive-compulsive disorder f.\tany persistent neurocognitive disorder"}
• {"criterion_text":"- Psychiatric hospitalization within current depressive episode. Participants with MDD that requires hospitalization are not eligible for the study."}
• {"criterion_text":"- Evidence or history of clinically significant disease which can affect the patients’ participation."}
• {"criterion_text":"- Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation."}
• {"criterion_text":"- Participant has a history of drug or alcohol use disorder."}
• {"criterion_text":"- Participants with a positive test for cannabinoids."}
• {"criterion_text":"- Clinically significant risk of suicide or harm to self or others."}
• {"criterion_text":"- History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode."}
• {"criterion_text":"- Borderline or antisocial personality disorder or other disorder of sufficient severity that judged by the Investigator could interfere with participation in this study."}

Primary endpoints

• {"endpoint_text":"- Change from Baseline to Visit 6 (Study Day 42) in Hamilton Depression Rating Scale-17 (HAM-D-17) total score","definition_or_measurement_approach":"Change from baseline to Visit 6 (Study Day 42) measured by total score on the HAM-D-17 questionnaire"}

Secondary endpoints

• {"endpoint_text":"- Change from Baseline to Visit 6 (Study Day 42) in Clinician Global Impression-Severity (CGI-S)","definition_or_measurement_approach":"Change from baseline to Visit 6 (Study Day 42) measured by the Clinician Global Impression - Severity (CGI-S) scale"}

Methods

• GP letters (GP Letter documents listed for multiple countries)
• Study brochures and leaflets (Study Brochure, leaflet documents listed per country)
• Website posts (document titles include 'website post')
• Social media posts (document titles include 'post instagram')
• Local recruitment arrangements and GP engagement (K1/K2 recruitment arrangements documents listed per country)
• Patient cards and participant handouts (Patient card / Participant Handout documents)

Romania

Earliest CTIS Part Ii Submission Date

31-07-2025

Latest Decision Or Authorization Date

11-08-2025

Processing Time Days

11

Number Of Sites

1

Number Of Participants

36

Bulgaria

Earliest CTIS Part Ii Submission Date

31-07-2025

Latest Decision Or Authorization Date

05-12-2025

Processing Time Days

127

Number Of Sites

3

Number Of Participants

26

Czechia

Earliest CTIS Part Ii Submission Date

20-07-2025

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

205

Number Of Sites

6

Number Of Participants

45

Hungary

Earliest CTIS Part Ii Submission Date

24-07-2025

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

249

Number Of Sites

3

Number Of Participants

24

Germany

Earliest CTIS Part Ii Submission Date

25-07-2025

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

245

Number Of Sites

4

Number Of Participants

22

Poland

Earliest CTIS Part Ii Submission Date

01-08-2025

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

271

Number Of Sites

11

Number Of Participants

87

Slovakia

Earliest CTIS Part Ii Submission Date

31-07-2025

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

277

Number Of Sites

3

Number Of Participants

26

Primary sponsor

Full Name

Seaport Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Premier Research Group S.L.

Responsibilities

Multiple sponsor duties (codes: 1,11,12,13,2,5,6,7,8) as listed in third-party duties

Third parties

• {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Medical imaging - ECG (sponsorDuties code: 15, value: Medical imaging - ECG)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Block Clinical Inc.","duties_or_roles":"Patient travel reimbursement, transport service (sponsorDuties code: 15)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"YES Print","duties_or_roles":"Printing services (sponsorDuties code: 15)","organisation_type":"SME"}
• {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"Completes packaging/labeling for US/EU release (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Massachusetts General Hospital","duties_or_roles":"Review of the SIGH-D and SCID audio recordings (sponsorDuties code: 15)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"EU release and distribution (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Branding services (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Spain","full_name":"Premier Research Group S.L.","duties_or_roles":"Multiple sponsor duties (codes: 1,11,12,13,2,5,6,7,8)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Etymax Limited","duties_or_roles":"Translation services (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"Rater Training and Audio Recordings (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"EMA Wellness LLC","duties_or_roles":"a validated eCOA smart phone application (dosing reminders) (sponsorDuties code: 15)","organisation_type":"Non-Pharmaceutical company"}