MedTrace Logo

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

NCT04589143 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2024-04-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-12-30
Completion
2023-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589143 on ClinicalTrials.gov