drugset / Trial / NCT00512070
Melatonin Metabolism Abnormality in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine
Completed
40 enrolled
Seattle Institute for Biomedical and Clinical Research
Eli Lilly and Company · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |