A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-center Study to Compare the Anti-Depressive Efficacy and Safety of Samyr® IM versus Placebo IM as an Enhancer Adjunctive to Antidepressant Treatment in Major Depression Disorder Patients Who have not Experienced Sufficient Symptoms Improvement Despite Antidepressant Treatment

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513022-29-00

Acronym

MYL-1603N-3002

Enrollment

468

Registered

2024-10-07

Start date

2019-01-09

Completion date

Unknown

Last updated

2026-01-20

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

Conditions

Major Depression Disorders

Brief summary

Change from baseline in the MADRS score after 7 days of treatment (visit 13).

Detailed description

MADRS change from baseline at scheduled visits., HRDS-6 (Per-Bech) change from baseline at scheduled visits., Change in CGI and PGI from baseline at scheduled visits.

Interventions

DRUGSamyr placebo (saline solution)

DRUGSodio Cloruro Fresenius Kabi Italia 0

DRUG9%

DRUGsolvente per uso parenterale

DRUGSAMYR 400 mg/5ml polvere e solvente per soluzione iniettabile

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in the MADRS score after 7 days of treatment (visit 13).	—

Secondary

Measure	Time frame
MADRS change from baseline at scheduled visits., HRDS-6 (Per-Bech) change from baseline at scheduled visits., Change in CGI and PGI from baseline at scheduled visits.	—

Countries

Italy

Outcome results

None listed

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