Melatonin for Prevention of Metabolic Side Effects of Olanzapine

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guilan University of Medical Sciences
• Treatments: Melatonin; Olanzapine

Criteria

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