Parkinson DiseasePD QOLNCT04590612
Improving Quality of Life in Early Parkinson's Disease
A study testing Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet and Citalopram in people with Parkinson Disease and Depression, run by Western University, Canada.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease, Depression
- What is being tested?
- Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet and Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
About this study
Official title: The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients
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.
- Conditions
- Parkinson Disease, Depression
- Being tested
- Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Citalopram
- Keywords
- de novo Parkinson disease, depression, quality of life, UPDRS
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbidopa-Levodopa 25 Mg-100 Mg Oral TabletDrug
Also called L-DOPA, l-3,4-dihydroxyphenylalanine, Sinemet
25mg-100mg tablets to be taken orally three times a day on an empty stomach
CitalopramDrug
Also called Celexa
20 mg tablet to be taken orally once and at the same time of the day, daily.
| Study group | Role | What they receive |
|---|---|---|
| Carbidopa-Levodopa | Active comparator | 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. Receives: Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet |
| Citalopram | Experimental | 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. Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandar Jog, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590612
- Sponsor's protocol ID
- 6450
- Acronym
- PD QOL
- Status last verified
- Oct 2020
- First submitted
- 17 Sep 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT04590612
- Acronym / sponsor ID
- PD QOL / 6450
- Conditions
- Parkinson Disease, Depression
- Keywords
- de novo Parkinson disease, depression, quality of life, UPDRS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbidopa-Levodopa | Active comparator | Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral TabletPatients 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. |
| Citalopram | Experimental | Drug: CitalopramPatients 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbidopa-Levodopa 25 Mg-100 Mg Oral TabletAlso: L-DOPA, l-3,4-dihydroxyphenylalanine, Sinemet25mg-100mg tablets to be taken orally three times a day on an empty stomach | Drug | Carbidopa-Levodopa |
| CitalopramAlso: Celexa20 mg tablet to be taken orally once and at the same time of the day, daily. | Drug | Citalopram |
Primary outcome
Difference between two arms in change of Short Form-36 (SF-36) scores
Time frame: 6 months
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.
3 secondary outcomes
Change in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination within Citalopram group
Time frame: 6 months
Difference between two arms in change of Unified Parkinson's Desease Rating Scale (UPDRS) part III motor examination
Time frame: 6 months
Difference between two arms in change of Patient Health Questionnaire -9 (PHQ-9) score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet and Citalopram in people with Parkinson Disease and Depression, run by Western University, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between two arms in change of Short Form-36 (SF-36) scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.