Olanzapine for Schizophrenia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Institute for Biomedical and Clinical Research

Must be taking: Atypical antipsychotics

Must not be taking: Fluvoxamine, Nifedipine, Warfarin

Disqualifiers: Pregnancy, Substance abuse, Head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

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

The subject or his/her legal representative must provide informed, written consent

Patients who the doctor thinks might need to switch to olanzapine will be excluded.

I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.

Exclusion Criteria

I am not pregnant or breastfeeding.

I have taken olanzapine in the last three months.

I do not have any major health issues that could worsen by joining this study or affect my participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Participants receive treatment with already established antipsychotic medication other than olanzapine or clozapine

2 weeks

Weekly visits for measurements

Olanzapine Treatment

Participants receive six weeks of treatment with olanzapine only

6 weeks

Weekly visits for measurements

Olanzapine and Melatonin Treatment

Participants receive six weeks of treatment with olanzapine and either 0.3 mg or 3.0 mg of melatonin

6 weeks

Weekly visits for measurements

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Melatonin
• Olanzapine

Trial Overview The study tests how the antipsychotic drug olanzapine affects melatonin levels in patients and whether taking melatonin can counteract changes caused by olanzapine. It's a pilot project focusing on individuals with specific mental health disorders.

How Is the Trial Designed?

Group I: IIB (3.0 mg/day melatonin) Experimental Treatment 1 Intervention

3.0 mg/day melatonin

Group II: IIA (0.3mg day melatonin) Experimental Treatment 1 Intervention

0.3mg day melatonin

Olanzapine is already approved in United States, European Union for the following indications:

Approved in United States as Zyprexa for:

• Schizophrenia
• Bipolar disorder
• Depression
• Nausea and vomiting associated with chemotherapy
• Off-label use for cancer cachexia and anorexia

Approved in European Union as Zyprexa for:

• Schizophrenia
• Bipolar disorder
• Depression
• Nausea and vomiting associated with chemotherapy

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials

55

Recruited

13,700+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

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