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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
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    September 17, 2020
    Last Updated
    October 15, 2020
    Sponsor
    Western University, Canada
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    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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