A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Compare the Anti-Depressive Efficacy and Safety of Samyr® Tablet versus Placebo Tablet on top of Adjunctive Antidepressant Treatment in Patients with Major Depression Disorder with Mild to Moderate Symptoms

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513019-29-00

Acronym

MYL-1603N-3001

Enrollment

600

Registered

2024-10-09

Start date

2024-03-22

Completion date

Unknown

Last updated

2025-07-08

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

Conditions

Major Depression Disorder

Brief summary

The primary endpoint is the change from baseline in the HDRS-17 score to visit 9 (Week 6).

Detailed description

Change from baseline of the PGI and CGI scales after 6 weeks of treatment (visit 9).

Interventions

DRUGSamyr placebo (same excipient as SAMYR)

DRUGSAMYR 400 mg compresse gastroresistenti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change from baseline in the HDRS-17 score to visit 9 (Week 6).	—

Secondary

Measure	Time frame
Change from baseline of the PGI and CGI scales after 6 weeks of treatment (visit 9).	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026