A Phase II, 6-week, multi-centre, randomised, double-blind (participant and investigator), placebo-controlled, dose-finding trial to evaluate the efficacy, tolerability, and safety of different doses of oral BI 1569912 as adjunctive therapy in patients with major depressive disorder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507942-10-00

Acronym

1447-0005

Enrollment

Registered

2024-07-02

Start date

2024-07-31

Completion date

2025-02-25

Last updated

2025-02-10

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

Conditions

Major depressive disorder

Brief summary

Change from baseline in MADRS total score at Week 6

Detailed description

Change from baseline in MADRS total score at Day 8, Response defined as ≥50% MADRS reduction from baseline at Day 8, Response defined as ≥50% MADRS reduction from baseline at Week 6, Remission defined as MADRS total score ≤10 at Week 6, Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8, Change from baseline in SMDDS total score at Week 4

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in MADRS total score at Week 6	—

Secondary

Measure	Time frame
Change from baseline in MADRS total score at Day 8, Response defined as ≥50% MADRS reduction from baseline at Day 8, Response defined as ≥50% MADRS reduction from baseline at Week 6, Remission defined as MADRS total score ≤10 at Week 6, Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8, Change from baseline in SMDDS total score at Week 4	—

Countries

Belgium, Bulgaria, Czechia, Germany

Outcome results