Melatonin for Prevention of Metabolic Side Effects of Olanzapine

Guilan University of Medical Sciences

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Drug: Melatonin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01593774

GUMS-9277

Details and patient eligibility

About

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.

Full description

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.

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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