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

NCT04589143 | Completed Phase 4

• 1 other identifier: Second Xiangya hospital
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

agomelatine; antidepressant; augmentation; major depressive disorder; early-nonresponsive

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Scale scores

  Depression severity; higher scores mean a worse outcome.

  Baseline (week 0), week 2, week 4, week 8

• Side Effect Rating Scale (SERS) scores

  Safety: frequency and severity of adverse events; higher scores mean a better outcome.

  Baseline (week 0), week 2, week 4, week 8

Secondary Outcomes (9)

• Patient Health Questionnaire (PHQ-9) scores

  Baseline (week 0), week 2, week 4, week 8

• Hamilton Anxiety Rating Scale (HAMA) scores

  Baseline (week 0), week 2, week 4, week 8

• General Anxiety Disorder-7 (GAD-7) scores

  Baseline (week 0), week 2, week 4, week 8

• Changes in Clinical Global Impression (CGI) scores

  Baseline (week 0), week 2, week 4, week 8

• Snaith-Hamilton Pleasure Scale (SHAPS) scores

  Baseline (week 0), week 2, week 4, week 8

Study Arms (2)

Experience group

EXPERIMENTAL

In this group,participants take agomelatine at a dose of 25-50 mg/d for 8 weeks.

Drug: Agomelatine

Contral group

PLACEBO COMPARATOR

In this group,participants take a placebo at a dose of 25-50 mg/d for 8 weeks.

Drug: Placebos

Interventions

Agomelatine DRUG

Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks

Experience group

Placebos DRUG

Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks

Contral group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• Current or previous history of brain organic diseases or loss of consciousness for more than 5 minutes.
• Current or previous history of major physical diseases (including rheumatic immune system diseases, endocrine and metabolic diseases, nervous system diseases, etc.).
• Current serious suicidal ideation or suicide attempt.
• Pregnancy or lactation in women.
• Color blindness (which would hinder neurocognitive testing).
• Use of anticoagulants (e.g., heparin, warfarin), glucocorticoids, or treatment for thyroid diseases in the past 3 months.
• Having received any neurocognitive assessment similar to this study in the past 12 months.
• Positive urine drug screening results or abnormal thyroid function test.
• Liver function tests showing transaminase (ALT and AST) levels 2 times above the upper limit of the normal range.
• Electrocardiogram examination revealing a QTc ≥ 430 ms in males or QTc ≥ 450 ms in females.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

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

Changsha, Hunan, 410001, China

Location

Related Publications (1)

• Ju Y, Ou W, Chen H, Yang L, Long Y, Liang H, Xi Z, Huang M, Chen W, Lv G, Shao F, Liu B, Liu J, Li Z, Liao M, Liang W, Yao Z, Zhang Y, Li L. Agomelatine as adjunctive therapy with SSRIs or SNRIs for major depressive disorder: a multicentre, double-blind, randomized, placebo-controlled trial. BMC Med. 2025 Mar 5;23(1):137. doi: 10.1186/s12916-025-03951-0.

  PMID: 40038707 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

agomelatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Chinese Psychiatry Society of Chinese Medical Association

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: October 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)