A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults with Major Depressive Disorder, With or Without Anxious Distress

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522347-18-00

Acronym

SPT-300-2024-204

Enrollment

231

Registered

2025-11-06

Start date

2025-11-26

Completion date

Unknown

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder (MDD), with or without Anxious Distress

Brief summary

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, Suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale

Detailed description

Change from Baseline to Visit 6 (Study Day 42) in the following: • HAM-D-17 total score • CGI-S • Hamilton Anxiety Rating Scale • PGI-S • Sheehan Disability Scale • The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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, Suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale	—

Secondary

Measure	Time frame
Change from Baseline to Visit 6 (Study Day 42) in the following: • HAM-D-17 total score • CGI-S • Hamilton Anxiety Rating Scale • PGI-S • Sheehan Disability Scale • The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form	—

Countries

Bulgaria, Czechia, Germany, Hungary, Poland, Romania, Slovakia

Outcome results