Overview

Prophylactic Effects of Agomelatine for Poststroke Depression

Status:
Not yet recruiting

Trial end date:
2024-05-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

First Affiliated Hospital, Sun Yat-Sen University

Treatments:

S 20098

Criteria

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