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NCT07161700
A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults With Major Depressive Disorder, With or Without Anxious Distress
Phase 2 trial testing SPT-300 in Major Depressive Disorder (MDD) in 360 participants. Enrolling by invitation.
1 May 2027
Quick facts
| Lead sponsor | Seaport Therapeutics |
|---|---|
| Phase | Phase 2 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 360 |
| Start date | 2 September 2025 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 May 2027 |
| Sites | 31 locations across United States, Bulgaria, Czechia, Germany, Poland, Slovakia |
Drugs / interventions tested
- SPT-300 — full drug profile →
Conditions studied
- Major Depressive Disorder (MDD) — all drugs for Major Depressive Disorder (MDD) →
- Major Depressive Disorder With Anxious Distress — all drugs for Major Depressive Disorder With Anxious Distress →
Sponsor
Seaport Therapeutics — full company profile →
Who can join
Adults 18 to 66, any sex, with Major Depressive Disorder (MDD) or Major Depressive Disorder With Anxious Distress. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and tolerability assessments based on Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and validated clinical scales and procedures
Time frame: Up to Day 49
Adverse events (AEs) are monitored from Day 1 to 49. A TEAE is as any AE with an onset after first dose of study treatment up to Day 49. Clinically significant abnormalities in clinical laboratory evaluations, ECGs, vital signs, physical examinations and Columbia Suicide Severity Rating Scale (C-SSRS) will be reported as TEAEs.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07161700
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Major Depressive Disorder (MDD)
Currently open trials in the same condition.
- NCT07396272 — A Clinical Trial of Add-on Oral Slow-release Ketamine Treatment in Major Depression · Phase 2 · recruiting
- NCT07226661 — Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder · Phase 2 · recruiting
- NCT07324070 — Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression · NA · recruiting
- NCT06972368 — Home-Based tDCS for Depression in BPD · NA · recruiting
- NCT07294924 — Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07161700 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Seaport Therapeutics
- Last refreshed: 15 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07161700.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing