Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics

NCT01811160 | Completed Phase 4

• 1 other identifier: INPRF_144
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Second Generation Antipsychotic Induced Metabolic Adverse Effects

Keywords

Melatonin; Second generation antipsychotic; bipolar disorder; schizophrenia; Metabolic

Outcome Measures

Primary Outcomes (1)

• Weight change

  Mean change from baseline weight at 8 weeks

Secondary Outcomes (15)

• Mean change in systolic blood pressure

  Mean change from baseline systolic blood pressure at 8 weeks

• Mean change diastolic blood pressure

  Mean change from baseline diastolic blood pressure at 8 weeks

• Mean change waist circumference

  Mean change from baseline waist circumference at 8 weeks

• Mean change hip circumference

  Mean change from baseline hip circumference at 8 weeks

• Mean change fat mass

  Mean change from baseline fat mass at 8 weeks

Study Arms (2)

Melatonin 5mg (extended release capsules)

EXPERIMENTAL

Subjects received melatonin (extended release) 5mg nightly during the follow up period

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Subjects received a placebo capsule nightly during the eight week follow up period.

Drug: Placebo

Interventions

Melatonin DRUG

A capsule of melatonin was administered nightly (20:00hrs).

Also known as: Melatonin 5mg capsules were administered at 20:00hrs during the follow up period.

Melatonin 5mg (extended release capsules)

Placebo DRUG

Placebo capsules were administered at 20:00hrs for eight weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and non-pregnant, non-lactating women aged between 18 and 45 years;
• DSM-IV-TR criteria for schizophrenia or bipolar disorder type I;
• free of concomitant medical or neurological illness (as per review of systems and general physical examination);
• free of DSM-IV current substance abuse or a history of substance dependence in the last six months;

You may not qualify if:

• were diagnosed with hypertension, diabetes mellitus, dyslipidemia, thyroid disorders or hepatic illness;
• had a history of hypersensitivity to melatonin;
• exhibited high risk for suicide or high risk for aggressiveness;
• 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.

Sponsors & Collaborators

• Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente: lead

Study Sites (1)

Instituto Nacional de Psiquiatría "Dr. Ramón de la Fuente"

Mexico City, México City, 14370, Mexico

Location

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Francisco Romo-Nava, MD

  Instituto Nacional de Psiquiatría / UNAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 14, 2013
• Study Start: October 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 14, 2013

Record last verified: 2013-03

Locations

ME (1)