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PRAISED: Prophylactic Effects of Agomelatine for Poststroke Depression

Sponsor
First Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05426304
Collaborator
(none)
420
Enrollment
2
Arms
20
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Agomelatine in the Prevention of Poststroke Depression
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Agomelatine

The Agomelatine group will be received agomelatine (25 mg/day) for 180 days.

Drug: Agomelatine
agomelatine 25 mg/day for 180 days
Other Names:
  • Agomelatine Tablets

    		•
    Placebo Comparator: Placebo

    The Placebo group will be received placebo (25 mg/day) for 180 days.

    Drug: Placebo Tablets
    placebo 25 mg/day for 180 days
    Other Names:
  • Placebo Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. rate of PSD within 180 days [180 days]

      PSD is defined as Hamilton Depression Rating Scale-17 (HAMD-17) ≥7 or diagnosis of depression by DSM-V.

    Secondary Outcome Measures

    1. rate of recurrence of ischemic stroke within 90 days [90±7 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.

    2. variation of HAMD-17 score from baseline [14±3 days, 28±3 days, 90±7 days, and 180±7 days]

      range from 0 to 50; the higher, the worse

    3. rate of sleep disorder [180 days]

      range from 0 to 21; > 7, having sleep disorder

    4. variation of Pittsburgh Sleep Quality Index (PSQI) score from baseline [14±3 days, 28±3 days, 90±7 days and 180±7 days]

      range from 0 to 21; the higher, the worse; > 7, having sleep disorder

    5. variation of Stroke Specific Quality of Life (SS-QOL) score from baseline [28±3 days, 90±7 days, and 180±7 days]

      range from 50 to 248; the higher, the better

    6. variation of Modified Rankin Scale (mRS) score from baseline [28±3 days, 90±7 days and 180±7 days]

      range from 0 to 5; the higher, the worse

    7. variation of National Institutes of Health Stroke Scale (NIHSS) from baseline [28±3 days, 90±7 days and 180±7 days]

      range from 0 to 42; the higher, the worse

    8. variation of Montreal Cognitive Assessment (MOCA) from baseline [28±3 days, 90±7 days, and 180±7 days]

      range from 0 to 30; the lower, the worse

    9. variation of Mini Mental State Examination (MMSE) score from baseline [28±3 days, 90±7 days, and 180±7 days]

      range from 0 to 30; the lower, the worse

    10. variation of Epworth Sleepiness Scale (ESS) from baseline [28±3 days, 90±7 days, and 180±7 days]

      range from 9 to 63; the higher, the worse

    11. rate of all-caused mortality [180 days]

      death due to all causes

    12. variation of Fatigue Severity Scale (FSS) from baseline [28±3 days, 90±7 days, and 180±7 days]

      range from 0 to 24; >=24, having drowsiness tendency

    13. rate of vascular events [180 days]

      defined as the composite of stroke, transient ischemic attack (TIA), myocardial infarction and vascular death

    14. rate of liver injury [28±3 days, 90±7 days]

      defend as the level of ALT 2 times higher than the upper limit of normal range

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. aged 18~75 years;

    2. within 7 days after stroke onset;

    3. CT or MRI showed lesions involving the frontal lobe;

    4. mRS≤2 before onset for recurrent ischemic stroke;

    5. HAMD-17<8 before enrollment;

    6. NIHSS<16;

    7. be consious and able to complete the relevant assessment scales.

    Exclusion Criteria:

    1. hemorrhagic stroke;

    2. with major depressive disorder, or have taken antidepressants within 30 days before stroke onset, or HAMD-17 ≥8;

    3. with other mental illnesses;

    4. history of drug abuse or alcohol dependence in the past 1 year

    5. with life-threatening illnesses or disorders which may affect the completion of the relevant assessment scale (e.g., hearing, language, visual impairment, etc.)

    6. with cognitive impairment who cannot complete the relevant assessment scale

    7. with serious neurodegeneration diseases (such as Parkinson's disease, Alzheimer's disease, etc.)

    8. infection or carriers of hepatitis B virus (HBV) or hepatitis C virus (HCV)

    9. 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

    10. renal dysfunction (creatinine clearance < 90 ml/min/1.73 m2)

    11. allergic to or contra-indicated to agomelatine

    12. lactose intolerance

    13. pregnant or breast-feeding women

    14. withdraw from other clinical trials within 4 weeks or participating in other clinical trials

    15. unsuitable for inclusion considered by the investigators

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • First Affiliated Hospital, Sun Yat-Sen University

    Investigators

    • Study Chair: Jinsheng Zeng, First Affiliated Hospital, Sun Yat-Sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jinsheng Zeng, MD, PhD, Professor, First Affiliated Hospital, Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT05426304
    Other Study ID Numbers:
    • PRAISED
    First Posted:
    Jun 21, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jinsheng Zeng, MD, PhD, Professor, First Affiliated Hospital, Sun Yat-Sen University
    poststroke depression, prevention, agomelatine
    Additional relevant MeSH terms:
    Ischemic Stroke
    Depression
    Depressive Disorder
    S 20098

    Study Results

    No Results Posted as of Jul 27, 2022