| Grant number: | 10/08840-0 |
| Support Opportunities: | Regular Research Grants |
| Start date: | September 01, 2010 |
| End date: | August 31, 2012 |
| Field of knowledge: | Biological Sciences - Pharmacology - Neuropsychopharmacology |
| Principal Investigator: | Sabine Pompéia |
| Grantee: | Sabine Pompéia |
| Host Institution: | Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil |
| City of the host institution: | São Paulo |
| Associated researchers: | Gilberto Mastrocola Manzano ; José Carlos Fernandes Galduroz |
Abstract
The acetylcholinsterase inhibitor donepezil has been increasingly used in the treatment of a series of neurologic and psychiatric disorders mainly due to its beneficial cognitive effects. This drug is also used in the treatment of mood disorders, apathy, irritability and panic disorders, but its detailed effects on mood have not been clearly described. The relation between the mood and cognitive changes induced by donepezil has also not been determined. Objetives: the aim of the present study is to investigate alterations in subjective sensations following single doses of donepezil (5 and 7.5 mg) and placebo in young, healthy volunteers by means of a large battery of scales/questionnaires that assess mood alterations. Methods: the experiment will follow a cross-over, double-blind design and include 15 young males (age range 18 to 30 years) with body mass index between 20 and 25 who are physically and mentally healthy. They will be randomly allocated to all the following treatments: donepezil 5 mg, donepezil 7.5 mg and placebo (talc). Three and a half hours after treatment (donepezil's Tmax) they will respond to a body symptoms scale (BSS) and mood questionnaires (VAMS; POMS; PANAS X) and will be submitted to some cognitive test (e.g. Psychomotor Vigilance Test, PVT) to determine the relations between mood and cognitive action of the drug. Before and after treatment participants will undergo an electroencephalogram (EEG), an objective measure of the drug effects. Plasma BDNF will also be measures at theoretical peak-plasma concentration because this factor is altered by donepezil and in mood disorders. Perspectives: the better characterization of the mood effects of donepezil may aid in the determination of its clinical profile as well as of the role of the cholinergic system in mood and cognition. (AU)
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