Assessing the effects of L-DOPA on psychomotor response in older adults with depression

Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial

This study is testing if L-DOPA, a medication usually used for Parkinson's, can help older adults with depression respond faster and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University of British Columbia (Academic / other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT06626152 on ClinicalTrials.gov

What this trial studies

This pilot feasibility trial investigates the impact of L-DOPA, a medication commonly used for Parkinson's disease, on psychomotor slowing in older adults suffering from major depressive disorder. Participants aged 60 and above with moderate to severe depression will be assessed for their psychomotor response after receiving L-DOPA. The study aims to explore the relationship between dopamine levels and psychomotor function in late-life depression, potentially providing insights into new treatment approaches. The trial will involve careful monitoring and adherence to intervention schedules to ensure participant safety and data integrity.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 60 years or older diagnosed with moderate to severe major depressive disorder.

Not a fit: Patients with major neurocognitive disorders or unstable medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for older adults with major depressive disorder by addressing psychomotor slowing.

How similar studies have performed: While the use of L-DOPA in treating depression is not widely established, there is emerging interest in its potential benefits, indicating a novel approach that may yield promising results.

Eligibility criteria

Inclusion Criteria:

* Outpatient persons capable of providing informed consent
* Minimum age of 60 years old
* MINI International Neuropsychiatric Interview diagnosis of major depressive disorder, based on DSM-5 criteria
* MADRS score of ≥15 (moderate/severe depression)
* On stable doses of psychotropic medication, including antidepressant medication, for at least 4 weeks
* Able to adhere to the intervention schedule

Exclusion Criteria:

* Current diagnosis of major neurocognitive disorder
* Current active psychosis
* Unstable medical illness, including clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease
* Diagnosis of narrow angle glaucoma
* Suspicious, undiagnosed skin lesions or a history of melanoma
* History of myocardial infarction
* Atrial, nodal, or ventricular arrhythmias
* History of seizures or seizure disorder
* History of peptic ulcer disease
* History of allergy or other hypersensitivity to levodopa, carbidopa, or to any other ingredient in the formulation of Levocarb
* Active suicidal ideation
* Psychotropic medication initiation or dose change \<4 weeks prior to enrolment
* Regular use of dopamine antagonist or benzodiazepines ≥2mg lorazepam equivalent per day
* Unable to complete neuropsychological testing in the English language
* Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)
* History of falls, with ≥1 fall per week during the past 4 weeks

Where this trial is running

Vancouver, British Columbia

• St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Study coordinator: Nicholas J Ainsworth, MD

Conditions Major Depressive Disorder