Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT04590612
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 50-80 years of age presenting with diagnoses of early stage Parkinson's Disease (UPDRS part III score \<20) without a previous treatment trial of either antidepressants or levodopa and able to provide consent.
* Screened positive with depressive symptoms suggestive of an underlying mild to moderate major depressive episode on the PHQ-9 (scores 10-20).
Exclusion Criteria:
* Currently taking an antidepressant (SSRI, SNRI, TCA, MAOi), antipsychotic, or dopaminergic Parkinson medication, or in the last 8 months.
* Tremor with a UPDRS-part III score of 3 or more.
* Currently participating in another clinical trial, which might directly influence findings of this study.
* Inability to provide informed consent.
* Dementia as defined by Montreal Cognitive Assessment (MoCA) score of \<24 and/or clinical evidence of dementia.
* A lifetime diagnosis of another mental disorder including bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, moderate and severe alcohol use disorder as per chart review or patient self-report.
* High risk of suicide (e.g. active suicidal ideation and/or current/recent intent or plan) as per self-report or relevant item on the PHQ-9.
* Non-correctable clinically significant sensory impairment.
* Unstable medical illnesses including delirium, uncontrolled diabetes mellitus, hypertension, and hyperlipidemia or cerebrovascular or cardiovascular risk factors that are not under medical management, including QTc\>480 on Electrocardiogram.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04590612
Study Brief:
Protocol Section:
NCT04590612