Melatonin for Prevention of Metabolic Side Effects of Olanzapine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to determine whether melatonin can prevent metabolic side effects of olanzapine such as weight gain, elevated glucose concentrations and lipid abnormalities.

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Detailed Description

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Atypical antipsychotics including olanzapine are associated with significant metabolic side effects. Animal studies have suggested that melatonin might prevent some of the olanzapine-associated side effects. Melatonin is safe and is widely used as a sleep-promoting complement, and is not associated with side effects seen with other used drugs such as metformin.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin

Tablet melatonin 3 mg/day at 9 pm as intervention group for eight week

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Tablet melatonin 3 mg/day at 9 pm as intervention group

Placebo

Placebo (with the same shape and taste as melatonin) at 9 pm as control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (with the same shape and taste as melatonin) at 9 pm as control group

Interventions

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Melatonin

Tablet melatonin 3 mg/day at 9 pm as intervention group

Intervention Type DRUG

Placebo

Placebo (with the same shape and taste as melatonin) at 9 pm as control group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-65 year
* First episode schizophrenia (DSM-IV-TR)
* Ability to take medicine orally
* Eligible for starting olanzapine

Exclusion Criteria

* Married women who are at reproductive age
* History of taking olanzapine in the recent 3 months
* History of allergy or intolerance to olanzapine
* History of significant head trauma ( causing loss of consciousness more than 5 minutes or neurological or cognitive sequels)
* Liver, kidney, cerebrovascular or cardiovascular disease
* Diabetes, metabolic syndrome
* Cancer
* Using antiepileptic (other than benzodiazepines for sleep) , antihypertensive, anticoagulant, anti-platelet drugs
* Using inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g. omeprazole. rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil)
* Delirium
* Need for administration of other antipsychotics
* Substance abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No