Melatonin for Prevention of Metabolic Side Effects of Olanzapine

Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.

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.

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.

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