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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experience group

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

Group Type EXPERIMENTAL

Agomelatine

Intervention Type DRUG

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

Contral group

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

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

Interventions

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Agomelatine

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

Intervention Type DRUG

Placebos

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No