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New treatment option for Major Depressive Disorder
Official title Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial
ClinicalTrials.gov ID: NCT06626152
What this study is testing
What is Apo-levocarb?
Apo-levocarb is an investigational medicine, given as an once-daily, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression (LLD), a condition that usually decreases a person's quality of life and is associated with other risks like physical frailty and dementia. A common feature of more severe LLD is psychomotor slowing, where a person's ability to think and move are impaired.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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
You likely can't join if
- Current diagnosis of major neurocognitive disorder
- Current active psychosis
- Unstable medical illness, including clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary...
- Diagnosis of narrow angle glaucoma
- Suspicious, undiagnosed skin lesions or a history of melanoma
- History of myocardial infarction
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.