Improving Quality of Life in Early Parkinson's Disease

Depression Clinical Trial

— PD QOL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04590612
• Other study ID #: 6450
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: January 2022

Study information

• Verified date: October 2020
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Parkinson Disease

Intervention

Drug:
• Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet
25mg-100mg tablets to be taken orally three times a day on an empty stomach
• Citalopram
20 mg tablet to be taken orally once and at the same time of the day, daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quantitative Electroencephalography (qEEG)	Network fragmentation will be analyzed by 5 mins of resting quantitative Electroencephalography (EEG), pre (baseline) and post (6-month followup) treatment. All frequency bands will be analyzed.	at baseline and at 6 months
Primary	Difference between two arms in change of Short Form-36 (SF-36) scores	Using a 6-month Randomized Controlled Trial (RCT) intervention study, assess whether Citalopram can improve Quality Of Life (QOL) significantly more than carbidopa-levodopa in early stage Parkinson's disease. This will be measured as a change in SF-36 scores, where the lower scores are associated with more disability. Scores range from 0-100.	6 months
Secondary	Change in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination within Citalopram group	Using a 6-months RCT intervention study, assess whether citalopram can improve motor function in early stage Parkinson's disease. Unified Parkinson's Disease Rating Scale part III motor examination indicates higher scores to be associated with more disability. Score ranges from 0 to 132.	6 months
Secondary	Difference between two arms in change of Unified Parkinson's Desease Rating Scale (UPDRS) part III motor examination	Using a 6-months RCT intervention study, assess whether citalopram can improve motor function equally or significantly more than carbidopa-levodopa in early stage Parkinson's disease.Unified Parkinson's Disease Rating Scale part III motor examination indicates higher scores to be associated with more disability. Score ranges from 0 to 132	6 months
Secondary	Difference between two arms in change of Patient Health Questionnaire -9 (PHQ-9) score	Using a 6-months RCT intervention study, assess whether citalopram can improve mood symptoms equally or significantly more than carbidopa-levodopa in early stage Parkinson's disease. Patient Health Questionnaire -9 (PHQ-9) higher score is associated with more disability. Scores range from 0-27.	6 months