Second Generation Antipsychotic Induced Metabolic Adverse Effects Clinical Trial
Official title:
Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
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
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment