Improving Quality of Life in Early Parkinson's Disease

The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients

NCT04590612•Western University, Canada

Summary

The study will examine 30 patients between ages 50-80, newly diagnosed with early-stage Parkinson's Disease. Patients will be randomized to receive either Citalopram or Carbidopa-levodopa. The investigators' primary outcome measure will be change in quality of life over a prospective period of 6 months. Secondary outcome measures will include change in mood state and motor symptoms, as well as comparison of improvement between two treatments. Primary investigators would also like to collect quantitative electroencephalogram (qEEG) recordings, which is a reading of brain activity as an additional interest of this study. Primary investigators will assess the qEEG recordings for electrophysiological findings before and after interventions.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

January 1, 2021

Primary Completion Date

January 1, 2022

Completion Date

January 1, 2022

Last Updated

October 19, 2020

Enrollment

ESTIMATED participants

Conditions

Parkinson DiseaseDepression

Interventions

Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet

DRUG

Citalopram

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Improving Quality of Life in Early Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Readiness and Progress in Emotion Regulation Therapy

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

[18F]F-DOPA Imaging in Patients With Autonomic Failure