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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04589143
• Other study ID #: Second Xiangya hospital
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2024
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

5. Education level of at least 6 years, with the ability to independently complete all scales and assessments.

6. Agreement from primary healthcare providers and patients to maintain current antidepressant treatment while adding agomelatine.

**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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Agomelatine
Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks
• Placebos
Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks

Locations

Country	Name	City	State
China	Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

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