Back to resultsProphylactic Effects of Agomelatine for Poststroke Depression (PRAISED)
Primary Purpose
Depression, Acute Ischemic Stroke
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Agomelatine
Placebo Tablets
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring poststroke depression, prevention, agomelatine
Eligibility Criteria
Inclusion Criteria:
- aged 18~75 years;
- within 7 days after stroke onset;
- CT or MRI showed lesions involving the frontal lobe;
- mRS≤2 before onset for recurrent ischemic stroke;
- HAMD-17<8 before enrollment;
- NIHSS<16;
- be consious and able to complete the relevant assessment scales.
Exclusion Criteria:
- hemorrhagic stroke;
- with major depressive disorder, or have taken antidepressants within 30 days before stroke onset, or HAMD-17 ≥8;
- with other mental illnesses;
- history of drug abuse or alcohol dependence in the past 1 year
- with life-threatening illnesses or disorders which may affect the completion of the relevant assessment scale (e.g., hearing, language, visual impairment, etc.)
- with cognitive impairment who cannot complete the relevant assessment scale
- with serious neurodegeneration diseases (such as Parkinson's disease, Alzheimer's disease, etc.)
- infection or carriers of hepatitis B virus (HBV) or hepatitis C virus (HCV)
- serum ALT level ≥ 2 times of the upper limit of the reference interval or TBIL level > 1.5 times of the upper limit of the reference interval
- renal dysfunction (creatinine clearance < 90 ml/min/1.73 m2)
- allergic to or contra-indicated to agomelatine
- lactose intolerance
- pregnant or breast-feeding women
- withdraw from other clinical trials within 4 weeks or participating in other clinical trials
- unsuitable for inclusion considered by the investigators
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Agomelatine
Placebo
Arm Description
The Agomelatine group will be received agomelatine (25 mg/day) for 180 days.
The Placebo group will be received placebo (25 mg/day) for 180 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
rate of recurrence of ischemic stroke within 90 days
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.
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.
exclude non ischemic causes.
variation of HAMD-17 score from baseline
range from 0 to 50; the higher, the worse
rate of sleep disorder
range from 0 to 21; > 7, having sleep disorder
variation of Pittsburgh Sleep Quality Index (PSQI) score from baseline
range from 0 to 21; the higher, the worse; > 7, having sleep disorder
variation of Stroke Specific Quality of Life (SS-QOL) score from baseline
range from 50 to 248; the higher, the better
variation of Modified Rankin Scale (mRS) score from baseline
range from 0 to 5; the higher, the worse
variation of National Institutes of Health Stroke Scale (NIHSS) from baseline
range from 0 to 42; the higher, the worse
variation of Montreal Cognitive Assessment (MOCA) from baseline
range from 0 to 30; the lower, the worse
variation of Mini Mental State Examination (MMSE) score from baseline
range from 0 to 30; the lower, the worse
variation of Epworth Sleepiness Scale (ESS) from baseline
range from 9 to 63; the higher, the worse
rate of all-caused mortality
death due to all causes
variation of Fatigue Severity Scale (FSS) from baseline
range from 0 to 24; >=24, having drowsiness tendency
rate of vascular events
defined as the composite of stroke, transient ischemic attack (TIA), myocardial infarction and vascular death
rate of liver injury
defend as the level of ALT 2 times higher than the upper limit of normal range
Full Information
NCT ID
NCT05426304
First Posted
May 2, 2022
Last Updated
July 26, 2022
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT05426304
Brief Title
Prophylactic Effects of Agomelatine for Poststroke Depression
Acronym
PRAISED
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Agomelatine in the Prevention of Poststroke Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Acute Ischemic Stroke
Keywords
poststroke depression, prevention, agomelatine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Agomelatine
Arm Type
Experimental
Arm Description
The Agomelatine group will be received agomelatine (25 mg/day) for 180 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The Placebo group will be received placebo (25 mg/day) for 180 days.
Intervention Type
Drug
Intervention Name(s)
Agomelatine
Other Intervention Name(s)
Agomelatine Tablets
Intervention Description
agomelatine 25 mg/day for 180 days
Intervention Type
Drug
Intervention Name(s)
Placebo Tablets
Other Intervention Name(s)
Placebo Placebo
Intervention Description
placebo 25 mg/day for 180 days
Primary Outcome Measure Information:
Title
rate of PSD within 180 days
Description
PSD is defined as Hamilton Depression Rating Scale-17 (HAMD-17) ≥7 or diagnosis of depression by DSM-V.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
rate of recurrence of ischemic stroke within 90 days
Description
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.
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.
exclude non ischemic causes.
Time Frame
90±7 days
Title
variation of HAMD-17 score from baseline
Description
range from 0 to 50; the higher, the worse
Time Frame
14±3 days, 28±3 days, 90±7 days, and 180±7 days
Title
rate of sleep disorder
Description
range from 0 to 21; > 7, having sleep disorder
Time Frame
180 days
Title
variation of Pittsburgh Sleep Quality Index (PSQI) score from baseline
Description
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
Title
variation of Stroke Specific Quality of Life (SS-QOL) score from baseline
Description
range from 50 to 248; the higher, the better
Time Frame
28±3 days, 90±7 days, and 180±7 days
Title
variation of Modified Rankin Scale (mRS) score from baseline
Description
range from 0 to 5; the higher, the worse
Time Frame
28±3 days, 90±7 days and 180±7 days
Title
variation of National Institutes of Health Stroke Scale (NIHSS) from baseline
Description
range from 0 to 42; the higher, the worse
Time Frame
28±3 days, 90±7 days and 180±7 days
Title
variation of Montreal Cognitive Assessment (MOCA) from baseline
Description
range from 0 to 30; the lower, the worse
Time Frame
28±3 days, 90±7 days, and 180±7 days
Title
variation of Mini Mental State Examination (MMSE) score from baseline
Description
range from 0 to 30; the lower, the worse
Time Frame
28±3 days, 90±7 days, and 180±7 days
Title
variation of Epworth Sleepiness Scale (ESS) from baseline
Description
range from 9 to 63; the higher, the worse
Time Frame
28±3 days, 90±7 days, and 180±7 days
Title
rate of all-caused mortality
Description
death due to all causes
Time Frame
180 days
Title
variation of Fatigue Severity Scale (FSS) from baseline
Description
range from 0 to 24; >=24, having drowsiness tendency
Time Frame
28±3 days, 90±7 days, and 180±7 days
Title
rate of vascular events
Description
defined as the composite of stroke, transient ischemic attack (TIA), myocardial infarction and vascular death
Time Frame
180 days
Title
rate of liver injury
Description
defend as the level of ALT 2 times higher than the upper limit of normal range
Time Frame
28±3 days, 90±7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18~75 years;
within 7 days after stroke onset;
CT or MRI showed lesions involving the frontal lobe;
mRS≤2 before onset for recurrent ischemic stroke;
HAMD-17<8 before enrollment;
NIHSS<16;
be consious and able to complete the relevant assessment scales.
Exclusion Criteria:
hemorrhagic stroke;
with major depressive disorder, or have taken antidepressants within 30 days before stroke onset, or HAMD-17 ≥8;
with other mental illnesses;
history of drug abuse or alcohol dependence in the past 1 year
with life-threatening illnesses or disorders which may affect the completion of the relevant assessment scale (e.g., hearing, language, visual impairment, etc.)
with cognitive impairment who cannot complete the relevant assessment scale
with serious neurodegeneration diseases (such as Parkinson's disease, Alzheimer's disease, etc.)
infection or carriers of hepatitis B virus (HBV) or hepatitis C virus (HCV)
serum ALT level ≥ 2 times of the upper limit of the reference interval or TBIL level > 1.5 times of the upper limit of the reference interval
renal dysfunction (creatinine clearance < 90 ml/min/1.73 m2)
allergic to or contra-indicated to agomelatine
lactose intolerance
pregnant or breast-feeding women
withdraw from other clinical trials within 4 weeks or participating in other clinical trials
unsuitable for inclusion considered by the investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsheng Zeng
Phone
13322800657
Email
zengjs@pub.guangzhou.gd.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsheng Zeng
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
12. IPD Sharing Statement
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Prophylactic Effects of Agomelatine for Poststroke Depression
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