drugset / Trial / NCT00512070

Melatonin Metabolism Abnormality in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine

NCT00512070

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Atypical antipsychotic medications, such as olanzapine, cause metabolic side effects, including weight gain, extra fat around the middle of the body, high blood sugar, and high cholesterol. One of the mechanisms by which these medications may cause these effects is by reducing plasma melatonin. This study is a pilot project to evaluate 1) the effect of olanzapine on melatonin secretion levels and 2) the effect of melatonin on olanzapine-induced changes in melatonin secretion in patients with schizophrenia, schizoaffective, or bipolar disorder.

Timeline

Start
2007-07
Primary completion
2010-12
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 0.3 mg Oral
Subject Melatonin Small molecule 3 mg Oral
Subject Olanzapine Small molecule 10 mg
Subject Olanzapine Small molecule 25 mg