Major Depressive Disorder
Conditions
Keywords
agomelatine, antidepressant, augmentation, major depressive disorder, early-nonresponsive
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.
Interventions
DRUGAgomelatine
Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks
DRUGPlacebos
Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks
Sponsors
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale scores | Baseline (week 0), week 2, week 4, week 8 | Depression severity; higher scores mean a worse outcome. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Changes in Clinical Global Impression (CGI) scores | Baseline (week 0), week 2, week 4, week 8 | Symptom severity; higher scores mean a worse outcome. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed