Improving Quality of Life in Early Parkinson's Disease

NCT ID: NCT04590612

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Citalopram

Intervention Type: DRUG

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

Interventions

Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet

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

Intervention Type: DRUG

Citalopram

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

Intervention Type: DRUG

Other Intervention Names

L-DOPA; l-3,4-dihydroxyphenylalanine; Sinemet; Celexa

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Mandar Jog

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

6450

Identifier Type: -

Identifier Source: org_study_id