post-stroke depression
Conditions
Interventions
Experimental Group:Idebenone + Escitalopram
Placebo control group:Placebo Idebenone + Escitalopram
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis meets the diagnostic criteria for post-stroke depressive disorder as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 2. History of ischaemic stroke within the past year, confirmed by MRI or CT scan; 3. Patients exhibit no significant impairment of consciousness and are able to cooperate with follow-up procedures; 4. If a screening-period subject is taking a prohibited medication as defined by the protocol, a one-month washout period is required prior to inclusion; 5. The patient or their legal guardian voluntarily signs an informed consent form; 6. Age 30 <=age <=80 years, male or female.
Exclusion criteria
Exclusion criteria: 1. Concurrent psychiatric disorders; 2. Presence of other severe physical illnesses, including organic brain disorders; 3. History of substance abuse or alcoholism; 4. Patients with pre-stroke depression; 5. Severe suicidal ideation or behaviour; 6. History of individual or familial epilepsy; 7. Use of antidepressants, electroconvulsive therapy, or repetitive transcranial magnetic stimulation within one month prior to enrolment; 8. Intellectual impairment, severe dementia (MMSE <=9), aphasia, or altered consciousness precluding compliance with follow-up; 9. Patients with severe cardiac disease, tuberculosis, hepatitis or other infectious diseases, or organ dysfunction such as hepatic or renal impairment; 10. Patients with allergy, intolerance or contraindications to the study drug; 11. Pregnant or breastfeeding women; 12. Patients deemed unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton rating scale for depression-24 (HAMD-24); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination (MMSE);Biomarkers (IL-1ß, IL-6, BDNF, GDF-15);Hamilton Anxiety Rating Scale (HAMA);Hamilton rating scale for depression-24 (HAMD-24);Adverse Events, Vital Signs, Clinical Laboratory Tests, 12-lead ECG;Patient Health Questionnaire-9 (PHQ-9);Alzheimer’s Disease Cooperative Study–Activities of Daily Living, 23-item (ADCS-ADL-23);Montreal Cognitive Assessment (MoCA); | — |
Countries
China
Contacts
Public ContactCuibai Wei
Xuanwu Hospital Capital Medical University
Outcome results
None listed