Clinical trial NCT01811160: Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
Official title: Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Second Generation Antipsychotic Induced Metabolic Adverse Effects
Keywords: Melatonin
Second generation antipsychotic
bipolar disorder
schizophrenia
Metabolic
Lead sponsor: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Men and non-pregnant, non-lactating women aged between 18 and 45 years;
2. DSM-IV-TR criteria for schizophrenia or bipolar disorder type I;
3. free of concomitant medical or neurological illness (as per review of systems and general physical examination);
4. free of DSM-IV current substance abuse or a history of substance dependence in the last six months;
5. who were initiated on continuous treatment with SGA (clozapine, olanzapine, quetiapine or risperidone) for a period no greater than the last three months prior to their inclusion to the present study.

Exclusion Criteria:

1. were diagnosed with hypertension, diabetes mellitus, dyslipidemia, thyroid disorders or hepatic illness;
2. had a history of hypersensitivity to melatonin;
3. exhibited high risk for suicide or high risk for aggressiveness;
4. women who were not practicing reliable forms of contraception. Patients were eliminated from the study if they suspended SGA or two consecutive doses of the study capsule at any point during the follow up period.

Primary outcomes:
measure: Weight change
timeFrame: Mean change from baseline weight at 8 weeks
Secondary outcomes:
measure: Mean change in systolic blood pressure
timeFrame: Mean change from baseline systolic blood pressure at 8 weeks
measure: Mean change diastolic blood pressure
timeFrame: Mean change from baseline diastolic blood pressure at 8 weeks
measure: Mean change waist circumference
timeFrame: Mean change from baseline waist circumference at 8 weeks
measure: Mean change hip circumference
timeFrame: Mean change from baseline hip circumference at 8 weeks
measure: Mean change fat mass
timeFrame: Mean change from baseline fat mass at 8 weeks
measure: Mean change lean mass
timeFrame: Mean change from baseline lean mass at 8 weeks
measure: Mean change total body water
timeFrame: Mean change from baseline total body water at 8 weeks
measure: Mean change glucose
timeFrame: Mean change from baseline glucose at 8 weeks
measure: Mean change low density lipoprotein
timeFrame: Mean change from baseline low density lipoprotein at 8 weeks
measure: Mean change high density lipoprotein
timeFrame: Mean change from baseline high density lipoprotein at 8 weeks
measure: Mean change triglycerides
timeFrame: Mean change from baseline triglycerides at 8 weeks
measure: Mean change cholesterol
timeFrame: Mean change from baseline cholesterol at 8 weeks
measure: Mean change Hamilton D scores
timeFrame: Mean change from baseline Hamilton D score at 8 weeks
measure: Mean change Young Mania rating scale
timeFrame: Mean change from baseline Young Mania rating scale at 8 weeks
measure: Mean change Positive and Negative Symptoms scale
timeFrame: Mean change from baseline Positive and Negative Symptoms scale at 8 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Psiquiatría "Dr. Ramón de la Fuente"
state: México City
Study officials:
affiliation: Instituto Nacional de Psiquiatría / UNAM
name: Francisco Romo-Nava, MD
role: PRINCIPAL_INVESTIGATOR
References: