Apathy
Conditions
Interventions
This is a randomized, placebo controlled, two arm clinical trial with double masking in which after participant selection according to inclusion and exclusion criteria and signing of the Informed Cons
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Universidade de São Paulo
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Age sixty years or older; diagnosis of major neurocognitive disorder; minimum score of four points on the Neuropsychiatric Inventory with alteration in the depression and or apathy domain; score on the Clinical Dementia Rating scale less than or equal to two; presence of a formal or informal caregiver able to adequately report the participant clinical status and assist with medication administration control; ability to return for reassessments when required and availability of a telephone for daily contact; signing of the Informed Consent Form agreeing to participate in the study; in case of use of psychotropic medications maintenance of a stable dose for at least thirty days
Exclusion criteria
Exclusion criteria: Clinical instability; use of alcohol other psychoactive substances and or sedative medications; delirium; psychotic disorder or presence of psychotic symptoms; bipolar disorder; unstable medical disease; contraindications to ketamine administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe improvement in depressive and anxiety symptoms in participants with major neurocognitive disorder, assessed through the variation of the depression and anxiety domain scores of the Neuropsychiatric Inventory between baseline assessment and the fourth week after the start of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that esketamine will be well tolerated and associated with a low frequency of adverse effects assessed through systematic recording of adverse events during the four week intervention period; it is expected to observe improvement in global cognition assessed by a standardized cognitive assessment instrument through comparison between baseline assessment and the fourth week | — |
Countries
Brazil
Contacts
Public ContactNathalia Novaretti
Universidade de São Paulo
Outcome results
None listed