Improving Quality of Life in Early Parkinson's Disease (PD QOL)
Primary Purpose
Parkinson Disease, Depression
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet
Citalopram
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring de novo Parkinson disease, depression, quality of life, UPDRS
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Carbidopa-Levodopa
Citalopram
Arm Description
Patients will be randomized to any of the 2 arms. In Levodopa/carbidopa arm, patients will be taking Carbidopa-Levodopa (25-100mg) three times a day for the duration of the study.
Patients will be randomized to any of the 2 arms. In Citalopram arm, patients will be taking Citalopram (20mg) daily for the duration of the study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
Full Information
NCT ID
NCT04590612
First Posted
September 17, 2020
Last Updated
October 15, 2020
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT04590612
Brief Title
Improving Quality of Life in Early Parkinson's Disease
Acronym
PD QOL
Official Title
The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Depression
Keywords
de novo Parkinson disease, depression, quality of life, UPDRS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carbidopa-Levodopa
Arm Type
Active Comparator
Arm Description
Patients will be randomized to any of the 2 arms. In Levodopa/carbidopa arm, patients will be taking Carbidopa-Levodopa (25-100mg) three times a day for the duration of the study.
Arm Title
Citalopram
Arm Type
Experimental
Arm Description
Patients will be randomized to any of the 2 arms. In Citalopram arm, patients will be taking Citalopram (20mg) daily for the duration of the study.
Intervention Type
Drug
Intervention Name(s)
Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet
Other Intervention Name(s)
L-DOPA, l-3,4-dihydroxyphenylalanine, Sinemet
Intervention Description
25mg-100mg tablets to be taken orally three times a day on an empty stomach
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Celexa
Intervention Description
20 mg tablet to be taken orally once and at the same time of the day, daily.
Primary Outcome Measure Information:
Title
Difference between two arms in change of Short Form-36 (SF-36) scores
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination within Citalopram group
Description
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.
Time Frame
6 months
Title
Difference between two arms in change of Unified Parkinson's Desease Rating Scale (UPDRS) part III motor examination
Description
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
Time Frame
6 months
Title
Difference between two arms in change of Patient Health Questionnaire -9 (PHQ-9) score
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
quantitative Electroencephalography (qEEG)
Description
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.
Time Frame
at baseline and at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Improving Quality of Life in Early Parkinson's Disease
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