None listed
Conditions
Interventions
Drug : This study will evaluate changes in depressive symptoms, sleep quality, non-motor and motor symptoms, cognitive function, and suicidality in patients with Parkinson’s disease following 24 weeks
Sponsors
Jeonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients visiting the Department of Neurology at Jeonbuk National University Hospital who are diagnosed with Parkinson’s disease based on the United Kingdom Parkinson’s Disease Society Brain Bank Criteria, aged 19 years or older, and meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for major depressive disorder will be enrolled. Eligible participants must have a score of 18 or higher on the Korean version of the Geriatric Depression Scale (K-GDS), report clinically significant depressive symptoms and insomnia, have maintained a stable dose and type of antiparkinsonian medication for at least 4 weeks, and provide written informed consent after receiving a full explanation of the study. A non-probability sampling method will be used, and participants will be consecutively recruited from patients who voluntarily consent to participate at the Department of Neurology, Jeonbuk National University Hospital.
Exclusion criteria
Exclusion criteria: 1.Patients showing a normal binding pattern on presynaptic dopaminergic transporter imaging 2.Patients with neurological disorders that may affect the assessment of Parkinson’s disease, such as stroke, severe head trauma, or other degenerative diseases including Parkinson’s disease dementia, or those with systemic diseases such as cancer or autoimmune disorders 3.Patients unable to appropriately respond to study questionnaires 4.Patients with contraindications to Proctin CR (fluoxetine controlled-release formulation), such as concomitant use of monoamine oxidase inhibitors or uncontrolled epilepsy 5.Patients with a score below 20 on the Korean version of the Mini-Mental State Examination (K-MMSE) 6.Patients with moderate or higher suicidal ideation or self-harm risk on the Columbia-Suicide Severity Rating Scale (C-SSRS), or those meeting item 9 (suicidal thoughts, plans, or attempts) of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria 7.Patients with a history of suicidal ideation, self-harm plan, or attempt within the past month, or those judged to be at high suicide risk by psychiatric evaluation 8.Patients with a history of drug overdose or self-poisoning 9.Pregnant or lactating women, or individuals (male or female) planning pregnancy or unwilling to use appropriate contraception during the study period 10.Any other condition that the principal investigator considers likely to compromise the participant’s safety or interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in depressive symptoms after administration of Fluoxetine controlled-release tablets (Proctin CR) in patients with Parkinson’s disease — change in the score of the Korean version of the Geriatric Depression Scale (K-GDS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in sleep disturbances after administration of Fluoxetine controlled-release tablets (Proctin CR) in patients with Parkinson’s disease — changes in the Scales for Outcomes in Parkinson’s Disease–Sleep (SCOPA-Sleep) and the Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire (RBDSQ) scores | — |
Countries
Korea, Republic of
Contacts
Public Contactjeon juhye
Jeonbuk National University Hospital
Outcome results
None listed