Improving Quality of Life in Early Parkinson's Disease (PD QOL)

• ClinicalTrials.gov Identifier: NCT04590612
• Recruitment Status: Not yet recruiting
• First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Sponsor: Western University, Canada
• Information provided by (Responsible Party): Mandar Jog, London Health Sciences Centre

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease; Depression	Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet; Drug: Citalopram	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients
• Estimated Study Start Date: January 2021
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Carbidopa-Levodopa; 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.	Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet; 25mg-100mg tablets to be taken orally three times a day on an empty stomach; Other Names: L-DOPA; l-3,4-dihydroxyphenylalanine; Sinemet
Experimental: Citalopram; 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.	Drug: Citalopram; 20 mg tablet to be taken orally once and at the same time of the day, daily.; Other Name: Celexa

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Change in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination within Citalopram group [ Time Frame: 6 months ]
   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.
2. Difference between two arms in change of Unified Parkinson's Desease Rating Scale (UPDRS) part III motor examination [ Time Frame: 6 months ]
   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
3. Difference between two arms in change of Patient Health Questionnaire -9 (PHQ-9) score [ Time Frame: 6 months ]
   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.

Other Outcome Measures:

1. quantitative Electroencephalography (qEEG) [ Time Frame: at baseline and at 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Mandar Jog, Principal Investigator, London Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT04590612
• Other Study ID Numbers: 6450
• First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Last Verified: October 2020

• 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

Keywords provided by Mandar Jog, London Health Sciences Centre:

de novo Parkinson disease; depression; quality of life; UPDRS

Additional relevant MeSH terms:

Parkinson Disease; Depression; Behavioral Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Citalopram; Dihydroxyphenylalanine; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Aromatic Amino Acid Decarboxylase Inhibitors; Enzyme Inhibitors; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents, Second-Generation; Antidepressive Agents