Olanzapine for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Amanda E Wood, PhD
Principal Investigator
VA Puget Sound Health Care System; University of Washington
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with schizophrenia, schizoaffective, or bipolar disorder who may benefit from olanzapine. Women must not be pregnant and should use contraception. Exclusions include recent substance abuse, prior olanzapine use within three months, certain medication use, significant head trauma history, allergy to olanzapine, or any serious health condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants receive treatment with already established antipsychotic medication other than olanzapine or clozapine
Olanzapine Treatment
Participants receive six weeks of treatment with olanzapine only
Olanzapine and Melatonin Treatment
Participants receive six weeks of treatment with olanzapine and either 0.3 mg or 3.0 mg of melatonin
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Melatonin
- Olanzapine
Olanzapine is already approved in United States, European Union for the following indications:
- Schizophrenia
- Bipolar disorder
- Depression
- Nausea and vomiting associated with chemotherapy
- Off-label use for cancer cachexia and anorexia
- Schizophrenia
- Bipolar disorder
- Depression
- Nausea and vomiting associated with chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Institute for Biomedical and Clinical Research
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University