NCT01593774

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Guilan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Melatonin	Tablet melatonin 3 mg/day at 9 pm as intervention group
DRUG	Placebo	Placebo (with the same shape and taste as melatonin) at 9 pm as control group

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-05-08
• Last updated: 2013-04-09

Locations

1 site across 1 country: Iran