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

RecruitingPhase 2Ages 60 Years - anyAllUniversity of British Columbia
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In plain words

What the trial is, and whether it could suit you

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. For example, they might not be able to walk or process information as quickly, and they might have problems with their working memory. Psychomotor slowing in LLD might be the result of a problem with the way a person's body produces or responds to the neurotransmitter dopamine. The drug Levodopa (L-DOPA), which can replace missing dopamine in the brain, has been used to treat to treat Parkinson's disease for many decades, and it might also affect psychomotor slowing in LLD. Methods In this study, participants are ad

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ15 (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 โ‰ฅ2mg 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 โ‰ฅ1 fall per week during the past 4 weeks
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What it tests

  • Apo-levocarb
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Where

1 site
St. Paul's Hospital
Vancouver, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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