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A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT04589143•Central South University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age between 18 and 60 years.
•2. Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for a current major depressive episode.
•3. Demonstrating an inadequate response to antidepressant treatment lasting at least 2 weeks, at the minimum effective dose for antidepressants. Inadequate response is defined as a \< 20% change in the Hamilton Depression Rating Scale-17 (HAMD-17) score or as per patients' self-report in the antidepressant treatment questionnaire. Minimum effective doses for some commonly used classes of antidepressants include:
•* Sertraline: \>50mg
•* Fluoxetine: \>20 mg
•* Citalopram: \>20 mg
•* Escitalopram: \>10mg
•* Venlafaxine: \>75 mg
•* Duloxetine: \>50 mg
•4. HAMD-17≥17; Clinical Global Impression-Severity (CGI-S) score ≥4.
+2 more criteria

Exclusion Criteria

•1. Meeting criteria for other psychiatric disorders according to DSM-IV (except generalized anxiety disorder), such as schizophrenia, bipolar disorder, or mental disorders related to alcohol and drug dependence.
•2. Current or previous history of brain organic diseases or loss of consciousness for more than 5 minutes.
•3. Current or previous history of major physical diseases (including rheumatic immune system diseases, endocrine and metabolic diseases, nervous system diseases, etc.).
•4. Current serious suicidal ideation or suicide attempt.
•5. Pregnancy or lactation in women.
•6. Color blindness (which would hinder neurocognitive testing).
•7. Use of anticoagulants (e.g., heparin, warfarin), glucocorticoids, or treatment for thyroid diseases in the past 3 months.
•8. Having received any neurocognitive assessment similar to this study in the past 12 months.
•9. Positive urine drug screening results or abnormal thyroid function test.
•10. Liver function tests showing transaminase (ALT and AST) levels 2 times above the upper limit of the normal range.
+1 more criteria

Locations (1)

Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Key Dates

Start Date

October 1, 2020

Primary Completion Date

December 30, 2022

Completion Date

January 30, 2023

Last Updated

April 1, 2024

Enrollment

137

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Agomelatine

DRUG

Placebos

DRUG

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Major Depressive Disorder

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression