Status:
UNKNOWN
Prophylactic Effects of Agomelatine for Poststroke Depression
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Depression
Acute Ischemic Stroke
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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, ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT05426304
Start Date
October 1 2022
End Date
May 31 2024
Last Update
July 27 2022
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