Epilepsy with depression
Conditions
Interventions
Control group:placebo pill
Experimental group:agomelatine 25mg
Experimental group2:agomelatine 50mg
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. In line with the epilepsy classification system released by the International Anti-Epilepsy Alliance (ILAE) in 2017, the subject's electroencephalogram (EEG) and brain CT scan or brain MRI examination results are consistent with the International Anti-Epilepsy Alliance seizure classification (2017 update) Epileptic seizures of focal onset (with or without impaired consciousness) and bilateral tonic-clonic seizures of focal onset progressing. EEG and brain CT scan or brain MRI results obtained before the screening visit are acceptable, regardless of when these results were obtained. If EEG and brain CT scan or brain MRI examination were not performed during the screening visit, the assessment should be completed at the first visit (hereinafter referred to as visit 1) or visit 1 and the results of the assessment should be obtained; 3. Although the subject has previously used no more than 3 AEDs drugs (simultaneous or second) treatment, a focal seizure of epilepsy must be observed within the first 2 years, and every 8 weeks before the baseline period. Within 28 days, at least 4 seizures of focal onset and the duration of "seizure-free" were no longer than 14 days; 4. Patients with focal onset epilepsy and depression meet the diagnostic criteria for depression specified in the Diagnostic Statistical Manual of Mental Disorders-Fourth Edition-Revised Draft (DSM-IV-TR), and the severity is mild to moderately severe; 5. According to the judgment of the investigator, the subject is believed to be reliable and able to comply with this plan (for example, understand and complete the diary), visit plan and medication arrangement, voluntarily participate in clinical research, and have signed informed consent.
Exclusion criteria
Exclusion criteria: 1.The subject has a known allergy to any component of the study drug; 2.Patients whose epileptic seizure frequency cannot be determined in the first three months of enrollment, and have clustered and uncountable seizures within 8 weeks prior to visit 1 (that is, each seizure lasts less than 30 minutes, and each seizure is less than 30 minutes). (The beginning and end of the second episode cannot be distinguished); 3.Patients with severe depression and suicidal tendencies; 4.The subject has taken research drugs, or participated in clinical trials such as melatonin receptor agonists, and terminated due to lack of efficacy or adverse events; 5.Patients with liver injury risk factors or known liver injury, including liver dysfunction, hepatitis B, hepatitis C patients/carriers, obesity/overweight/non-alcoholic fatty liver, diabetes, excessive drinking, or taking may cause liver Damaged drugs, etc; 6.The subject has sick sinus syndrome, no pacemaker or second/third-degree atrioventricular (AV) block, or any other clinically significant ECG abnormalities; 7.The subject has a known sodium channel disease, such as Brugada syndrome; 8.The subject has had a myocardial infarction in the past 3 months; 9.Subjects have heart failure grade III or IV by the New York Society of Cardiology; 10.The subject has a diagnosis of false seizures, conversion disorders, or other non-seizure events that are easily confused with seizures at present or in the past; 11. The subject has participated in another investigational drug (IMP) or medical device research within 2 months prior to visit 1, has participated in other clinical trials in the past 3 months, or is currently participating in another experimental drug Drug or medical device research; 12. At Visit 1, the subject's renal function was impaired (ie, the creatinine clearance rate [CLcr] was less than 30 mL/min). Creatinine clearance rate will be evaluated by the following method: Adult male: CLcr = (140-age) x body weight (in kg)/(72 x serum creatinine (in mg/dL)) adult female: CLcr = ([140-age ] x weight (unit kg)/[72 x serum creatinine (unit mg/dL)]) x 0.85; 13.At Visit 1, the subject's ALT, AST, or total bilirubin level >=2 times ULN or alkaline phosphatase level >=3 times ULN; 14. Within 12 months before Visit 1, the subject had a history of status epilepticus; 15. The subject had undergone epilepsy surgery during the 2 years prior to Visit 1; 16. The subject has a history of primary generalized seizures; 17. The subject is in a certain medical or mental state, and the investigator believes that this state may endanger the health of the subject or the subjects ability to participate in this research; 18. The subject suffers from other medical, neurological, and mental diseases, such as abnormal thyroid function, dementia, Parkinson's syndrome, schizophrenia, etc.; 19. The subject suffers from a medical condition that the investigator believes is expected to interfere with the absorption, distribution, metabolism, or excretion of the study drug; 20. The subject is receiving ketogenic diet therapy; 21. Patients with tumors may have suffered from tumors; 22. During pregnancy, lactation, recent preparations for pregnancy or spouse preparations for pregnancy, and patients taking estrogen for contraception; 23. Take ciprofloxacin, enoxacin, grepafloxacin, propranolol, rifampin; 24. Have taken benzodiazepine sedatives and hypnotics within 7 days before enrollment, and have taken antidep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale;Addenbrooke's Cognitive Examination Revised;Hamilton Anxiety Scale;Video electroencephalogram;the frequency of seizures; | — |
Secondary
| Measure | Time frame |
|---|---|
| Epilepsy Diary;Sleep Diary; | — |
Countries
China
Contacts
Public ContactWang Yuping
Xuanwu Hospital Capital Medical University
Outcome results
None listed