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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
137
Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks
Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Hamilton Depression Scale scores
Depression severity; higher scores mean a worse outcome.
Time frame: 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.
Time frame: Baseline (week 0), week 2, week 4, week 8
Patient Health Questionnaire (PHQ-9) scores
Self-report depression severity; higher scores mean a worse outcome.
Time frame: Baseline (week 0), week 2, week 4, week 8
Hamilton Anxiety Rating Scale (HAMA) scores
Anxiety severity; higher scores mean a worse outcome.
Time frame: Baseline (week 0), week 2, week 4, week 8
General Anxiety Disorder-7 (GAD-7) scores
Self-report anxiety severity; higher scores mean a worse outcome.
Time frame: Baseline (week 0), week 2, week 4, week 8
Changes in Clinical Global Impression (CGI) scores
Symptom severity; higher scores mean a worse outcome.
Time frame: Baseline (week 0), week 2, week 4, week 8
Snaith-Hamilton Pleasure Scale (SHAPS) scores
Self-reported severity of anhedonia; higher scores mean a worse outcome.
Time frame: Baseline (week 0), week 2, week 4, week 8
Sheehan Disability Scale (SDS) scores
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Self-report tool that assesses functional impairment in work/school, social life, and family life; higher scores mean a worse outcome.
Time frame: Baseline (week 0), week 2, week 4, week 8
Quality of life (EQ-5D-3L) scores
Self-report Quality of life; higher scores mean a better outcome.
Time frame: Baseline (week 0), week 2, week 4, week 8
performance of Neurocognitive test, including executive function, attention, processing speed, and memory
Neurocognitive function; higher scores mean a better outcome.
Time frame: Baseline (week 0), week 2, week 4, week 8
Athens Insomnia Scale (AIS) scores
Self-report severity of insomnia; higher scores mean a worse outcome.
Time frame: Baseline (week 0), week 2, week 4, week 8