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

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebos; Drug: Agomelatine

• Registration Number: NCT04589143
• Lead Sponsor: Central South University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Not provided

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.
11. Electrocardiogram examination revealing a QTc ≥ 430 ms in males or QTc ≥ 450 ms in females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contral group	Placebos	In this group,participants take a placebo at a dose of 25-50 mg/d for 8 weeks.
Experience group	Agomelatine	In this group,participants take agomelatine at a dose of 25-50 mg/d for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Side Effect Rating Scale (SERS) scores	Baseline (week 0), week 2, week 4, week 8	Safety: frequency and severity of adverse events; higher scores mean a better outcome.
Hamilton Depression Scale scores	Baseline (week 0), week 2, week 4, week 8	Depression severity; higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Quality of life (EQ-5D-3L) scores	Baseline (week 0), week 2, week 4, week 8	Self-report Quality of life; higher scores mean a better outcome.
performance of Neurocognitive test, including executive function, attention, processing speed, and memory	Baseline (week 0), week 2, week 4, week 8	Neurocognitive function; higher scores mean a better outcome.
General Anxiety Disorder-7 (GAD-7) scores	Baseline (week 0), week 2, week 4, week 8	Self-report anxiety severity; higher scores mean a worse outcome.
Changes in Clinical Global Impression (CGI) scores	Baseline (week 0), week 2, week 4, week 8	Symptom severity; higher scores mean a worse outcome.
Patient Health Questionnaire (PHQ-9) scores	Baseline (week 0), week 2, week 4, week 8	Self-report depression severity; higher scores mean a worse outcome.
Hamilton Anxiety Rating Scale (HAMA) scores	Baseline (week 0), week 2, week 4, week 8	Anxiety severity; higher scores mean a worse outcome.
Athens Insomnia Scale (AIS) scores	Baseline (week 0), week 2, week 4, week 8	Self-report severity of insomnia; higher scores mean a worse outcome.
Snaith-Hamilton Pleasure Scale (SHAPS) scores	Baseline (week 0), week 2, week 4, week 8	Self-reported severity of anhedonia; higher scores mean a worse outcome.
Sheehan Disability Scale (SDS) scores	Baseline (week 0), week 2, week 4, week 8	Self-report tool that assesses functional impairment in work/school, social life, and family life; higher scores mean a worse outcome.

Trial Locations

Locations (1)

Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China