The incidence of depression in stroke patients with frontal lobe involvement was reported to be as high as 42%. Agomelatin, a type 1/2 melatonin receptor agonist and serotonin 2C receptor antagonist, is effective in treatment of depression, but whether it can prevent poststroke depression (PSD) remains unknown. The PRAISED trial is a multicenter, randomized, double-blind trial and is designed to evaluate the efficacy and safety of agomelatine in the prevention of PSD in stroke patients with frontal lobe involvement. The primary outcome is the rate of post-stroke depression for 180 days.
This PRAISED trial is a multicenter, randomized, double-blind trial to evaluate the efficacy and safety of agomelatine in the prevention of PSD in patients with acute ischemic stroke. The sample size is 420. The participants will be randomized to receive a 6-month treatment of agomelatine 25mg/d or placebo 25mg/d. The primary end point is the proportion of PSD within 180 days. PSD is defined as the Hamilton Depression Rating Scale-17 (HAMD-17) ≥7 or diagnosis of depression by the Diagnostic and Statistical Manual of mental disorders-V (DSM-V). The second end point are rate of recurrence of ischemic stroke within 90 days, modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), vascular death, transient ischemic attack (TIA)/stroke or myocardial infarction during the 6-months, cognitive function(Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS), Stroke Specific Quality Of Life (SS-QOL) scale, adherence to medication, adverse events. The study consists of five visits including the day of randomization, day 14±3 days, day 28±3 days, day 90±7 days, day 180±7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
420
agomelatine 25 mg/day for 180 days
placebo 25 mg/day for 180 days
rate of PSD within 180 days
PSD is defined as Hamilton Depression Rating Scale-17 (HAMD-17) ≥7 or diagnosis of depression by DSM-V.
Time frame: 180 days
rate of recurrence of ischemic stroke within 90 days
1. Acute onset of focal neurological deficit, a few can be comprehensive neurological deficit. 2. Brain CT/MRI confirms the corresponding infarct focus in the brain, or the symptoms and signs continue for more than 24h, or cause death within 24h. 3. Exclude non-ischemic causes. 2. brain ct/mri confirmed the corresponding infarct focus in the brain, or the symptoms and signs continued for more than 24h, or caused death within 24h. 3. exclude non ischemic causes.
Time frame: 90±7 days
variation of HAMD-17 score from baseline
range from 0 to 50; the higher, the worse
Time frame: 14±3 days, 28±3 days, 90±7 days, and 180±7 days
rate of sleep disorder
range from 0 to 21; \> 7, having sleep disorder
Time frame: 180 days
variation of Pittsburgh Sleep Quality Index (PSQI) score from baseline
range from 0 to 21; the higher, the worse; \> 7, having sleep disorder
Time frame: 14±3 days, 28±3 days, 90±7 days and 180±7 days
variation of Stroke Specific Quality of Life (SS-QOL) score from baseline
range from 50 to 248; the higher, the better
Time frame: 28±3 days, 90±7 days, and 180±7 days
variation of Modified Rankin Scale (mRS) score from baseline
range from 0 to 5; the higher, the worse
Time frame: 28±3 days, 90±7 days and 180±7 days
variation of National Institutes of Health Stroke Scale (NIHSS) from baseline
range from 0 to 42; the higher, the worse
Time frame: 28±3 days, 90±7 days and 180±7 days
variation of Montreal Cognitive Assessment (MOCA) from baseline
range from 0 to 30; the lower, the worse
Time frame: 28±3 days, 90±7 days, and 180±7 days
variation of Mini Mental State Examination (MMSE) score from baseline
range from 0 to 30; the lower, the worse
Time frame: 28±3 days, 90±7 days, and 180±7 days
variation of Epworth Sleepiness Scale (ESS) from baseline
range from 9 to 63; the higher, the worse
Time frame: 28±3 days, 90±7 days, and 180±7 days
rate of all-caused mortality
death due to all causes
Time frame: 180 days
variation of Fatigue Severity Scale (FSS) from baseline
range from 0 to 24; \>=24, having drowsiness tendency
Time frame: 28±3 days, 90±7 days, and 180±7 days
rate of vascular events
defined as the composite of stroke, transient ischemic attack (TIA), myocardial infarction and vascular death
Time frame: 180 days
rate of liver injury
defend as the level of ALT 2 times higher than the upper limit of normal range
Time frame: 28±3 days, 90±7 days
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