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:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT04301492
Eligibility Criteria:
Inclusion Criteria:
* • Male and female of every ethnic group, age 30 to 80 years
* Diagnosis of Parkinson's disease according UK Brain Bank Criteria
* Hoehn \&Yahr: stage 1 to 3
* Patients with diagnosis of sustained depression
* Hamilton Depression Rating Scale score (HAM-D-17) ≥ 14
* Beck Depression Inventory score (BDI)≥13
* Stable doses of antiparkinsonian drugs for at least 4 weeks.
* Patients able to understand and provide written informed consent
* Female patients in post-menopausal state with at least one year absence of vaginal bleeding or spotting or be surgically sterile
* Women of childbearing potential must use an acceptable method of contraception
* Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study
Exclusion Criteria:
* • Atypical Parkinsonism.
* Subjects at risk of suicide (with a score ≥ 3 at the Item 3 of the HAM-D-17)
* Any significant psychiatric, metabolic and systemic significant concomitant disease
* Patients with clinically significant out of range laboratory values
* Patients with history of epileptic seizures
* Subjects with Dopa Dysregulation Syndrome (DDS)
* Subjects treated with irreversible IMAO and IMAO-A
* Use of vortioxetine in the past 30 days
* Patient treated with oral anticoagulant
* Patients participating in a clinical trial in the last 6 weeks
* Patients with moderate-severe cognitive decline not able to provide consent form
* Patients currently lactating or pregnant or planning to become pregnant during the duration of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT04301492
Study Brief:
Protocol Section:
NCT04301492