NCT04589143

A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine

Agomelatine Augmentation in Early-Nonresponsive Patients With Major Depressive Disorder Receiving SSRIs or SNRIs: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to investigate the efficacy and safety of antidepressant augmentation with agomelatine in the treatment of patients with depression who did not demonstrate satisfying response to selective serotonin reuptake inhibitor (SSRI) and serotonin-noradrenaline reuptake inhibitor (SNRI) during their early phase of treatment; this study also aims to explore the effects of augmenting antidepressant treatment with agomelatine on various aspects, including sleep quality, quality of life, social functioning, and cognitive function in patients with MDD.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Agomelatine	Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks
DRUG	Placebos	Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-12-30
• Completion: 2023-01-30
• First posted: 2020-10-19
• Last updated: 2024-04-01

Locations

1 site across 1 country: China