Improving Quality of Life in Early Parkinson's Disease

NCT04590612 | Unknown DMC

• 1 other identifier: 6450
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination within Citalopram group

  6 months

• Difference between two arms in change of Unified Parkinson's Desease Rating Scale (UPDRS) part III motor examination

  6 months

• Difference between two arms in change of Patient Health Questionnaire -9 (PHQ-9) score

  6 months

Other Outcomes (1)

• quantitative Electroencephalography (qEEG)

  at baseline and at 6 months

Study Arms (2)

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.

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.

Drug: Citalopram

Interventions

Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet DRUG

25mg-100mg tablets to be taken orally three times a day on an empty stomach

Also known as: L-DOPA, l-3,4-dihydroxyphenylalanine, Sinemet

Carbidopa-Levodopa

Citalopram DRUG

20 mg tablet to be taken orally once and at the same time of the day, daily.

Also known as: Celexa

Citalopram

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

carbidopa, levodopa drug combination; Levodopa; Citalopram

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10