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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT04497168
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a Parkinson Disease (PD) diagnosis based on the United Kingdom Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria
* Modified Hoehn and Yahr (HY) scores spanning 2.0 to 3.0
* Age 65 years or greater
Exclusion Criteria:
* Diagnosis of an atypical parkinsonian condition
* Participants on neuroleptics and participants with a history of use of anti-depressants (including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), bupropion, St. John's Wort or other serotoninergic agents in the year preceding study enrollment
* Evidence of a large artery stroke or mass lesion on brain imaging
* Participants with a life threatening comorbid illness
* Severe claustrophobia precluding PET imaging
* Inability to participate in research procedures involving ionizing radiation
* Pregnancy or breastfeeding
* Participants with active depression as defined by a Geriatric Depression Scale score of \>10 or on the basis of clinical diagnosis by the PI
* Participants who report active suicidal ideation as defined by an affirmative answer to questions 1 and 2 on the C-SSRS
* Participants with baseline HY scores \<2.0 or ≥3.0
* Participants with a QTc interval on baseline EKG \>0.45 for men or \>0.47 for women
* Subjects taking certain contraindicated medications at baseline
* Subjects unable to swallow pills
* Subjects with a previous history of mania, ongoing hepatic impairment or epilepsy
* Subjects with a known allergy to citalopram or escitalopram
* Subjects with substantial cognitive impairment or dementia that would prevent them from providing informed consent
* Subjects in another ongoing clinical trial
* Subjects with treatment-naieve Parkinson disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04497168
Study Brief:
Protocol Section:
NCT04497168