Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
Schizophrenia and bipolar disorder are frequently associated with an elevated risk for
obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic
disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute
and long term treatment of these disorders and are considered a first option on most
treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight gain,
disturbed glucose and lipid regulation and an increase of cardiovascular risk and mortality
as well as non- adherence to treatment. There are several hypotheses attempting to explain
the complex pathways that lead to antipsychotic therapeutic effects and their accompanying
adverse effects. Recently, in animals receiving SGA, melatonin prevented to a large extent
the body weight increase, which indicates a possible role for biological rhythms in SGA
induced body weight accumulation. Melatonin is a hormone secreted by the pineal gland that
follows a circadian rhythm with an increased secretion in the middle of the night. This
hormone acts importantly on the suprachiasmatic nucleus and other areas in the brain and
periphery. Thus melatonin is involved in a series of biological functions such as sleep
regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and more
recently in the regulation of metabolic processes including insulin, leptin, and lipid
regulation.
Given previous results in experimental animals, the purpose of the present study is to test
the potential effect of melatonin in reducing or preventing some of the metabolic
disturbances associated with SGA
Phase:
Phase 4
Details
Lead Sponsor:
Instituto Nacional de PsiquiatrÃa Dr. Ramón de la Fuente