None listed
Conditions
Interventions
Drug : 1. Drug Name and Dose:
1) Mirtazapine: Initial dose is 7.5mg/day for the first 4 weeks, followed by 15mg/day for the next 4 weeks. The final dose is 15-45mg/day.
2) Paroxetine: Initial dose is
Sponsors
Jeonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults aged 19 years or older. - Patients diagnosed with Parkinson’s disease according to the United Kingdom Parkinson’s Disease Society Brain Bank Criteria. - Patients who meet the DSM-V criteria for major depressive disorder and have a Geriatric Depression Scale score of 18 or higher, and who clinically exhibit symptoms of depression along with insomnia. - Patients whose type or dosage of Parkinson's disease medication has not changed in the last four weeks. - Patients who have received detailed explanations about the study, fully understand it, and voluntarily decide to participate by providing written consent. - Patients who are willing and able to cooperate with the study and complete all clinical trial stages.
Exclusion criteria
Exclusion criteria: - Patients showing a normal binding pattern on presynaptic dopaminergic transporter imaging. - Patients with significant neurological disorders that could affect the evaluation of Parkinson's disease, such as stroke, severe head trauma, other chronic degenerative diseases (including Parkinson's disease dementia), or patients with non-neurological disorders that could significantly affect their general condition, such as cancer or autoimmune diseases. - Patients who are expected to have difficulty responding appropriately to the study questionnaires. - Patients with contraindications to Mirtazapine and Paroxetine based on product data. - Patients with clinically significant cognitive impairment - Women who are pregnant or breastfeeding, or women of childbearing potential who are confirmed to be pregnant during a screening visit interview, or those planning to become pregnant during the clinical trial period, and women or men who do not agree to use contraception.* * Permissible methods of contraception: One of the following methods must be used. ? Hormonal contraception, intrauterine device, vasectomy, or bilateral tubal ligation ? Combined use of male condom, female condom, cervical cap, contraceptive diaphragm, or contraceptive sponge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment scales for depression symptoms and sleep: Korean version of Geriatric Depression Scale (K-GDS), SCOPA-Sleep | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect on each individual non-motor and motor symptoms of Parkinson's disease: RBDSQ, K-MMSE score, K-NMSS, MDS-UPDRS Part 2, 3, 4, HY scale;Effect on neuropsychiatric symptoms based on the Neuropsychiatric Inventory questionnaire: Korean version of NPI-Q | — |
Countries
Korea, Republic of
Contacts
Public ContactYun Su Hwang
Jeonbuk National University Hospital
Outcome results
None listed