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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how olanzapine, a medication for schizophrenia and bipolar disorder, affects melatonin levels in the body. Researchers aim to determine if melatonin supplements can help manage olanzapine's side effects, such as weight gain and high blood sugar. Participants will be divided into groups to receive different melatonin doses. The trial seeks individuals diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder who might benefit from switching to olanzapine. As an unphased trial, this study offers a unique opportunity to contribute to understanding how melatonin might improve treatment outcomes.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop using fluvoxamine, nifedipine, or warfarin for 30 days before starting. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that melatonin is generally safe for people with schizophrenia. Studies have found that it can improve sleep and address some metabolic issues often caused by antipsychotic medications. For example, one study found that melatonin reduced negative symptoms by 33.5% after six weeks, without any serious side effects. Another source suggests that melatonin could be an affordable and safe way to enhance treatment outcomes.

Olanzapine has already received FDA approval for treating schizophrenia and bipolar disorder. However, it can cause metabolic side effects, such as weight gain and high blood sugar. This trial aims to determine if melatonin can help reduce these side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of melatonin in combination with olanzapine for schizophrenia because it explores a novel approach to treatment that targets sleep and circadian rhythm disruptions, which are often issues for people with this condition. Unlike standard antipsychotic treatments that primarily focus on dopamine regulation, melatonin offers a potential adjunctive therapy that may improve sleep quality and enhance overall treatment outcomes. This approach could lead to more comprehensive management of schizophrenia symptoms, providing benefits beyond what current medications can achieve alone.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

This trial will evaluate the effects of melatonin on schizophrenia symptoms. Research has shown that melatonin can help with some symptoms in people with schizophrenia. One study found that melatonin reduced certain symptoms by 33.5% without causing serious side effects. It also appears to aid sleep; a study found that taking 2 mg of controlled-release melatonin improved sleep quality. Additionally, melatonin might help with weight and movement problems caused by antipsychotic medications. While these results are promising, more research is needed to fully understand how melatonin can benefit people with schizophrenia. ^{1 2 3 5 6}

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8394692/

Therapeutic use of melatonin in schizophrenia Adjunctive melatonin therapy has some positive outcomes for sleep, metabolic profile and tardive dyskinesia in patients with schizophrenia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10293691/

Evaluating the Effect of Melatonin on Positive and Negative ... Our results showed that melatonin can alleviate the negative symptoms of schizophrenia by 33.5% after six weeks of treatment without serious side effects ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06838104

Study Details | NCT06838104 | Effect of Melatonin on ... If proven effective, melatonin supplementation could offer a low-cost, well-tolerated intervention to enhance treatment outcomes in schizophrenia patients, ...

4. link.springer.com link.springer.com/article/10.1007/s11920-022-01369-6

Role of Melatonin in the Management of Sleep and ... One RCT with 19 schizophrenia patients reported that controlled-release melatonin 2 mg significantly improved sleep efficiency compared to ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306453018307418

Pineal gland and schizophrenia: A systematic review and ... Melatonin therapy fosters slight improvements of sleep and of antipsychotic Sequels. •. Treatment with low-dose melatonin is chronobiotically effective, but for ...

6. mdpi.com mdpi.com/1422-0067/14/5/9037

Role of Melatonin in Schizophrenia In this paper, both aspects of melatonin application are reviewed. Its clinical use in schizophrenia is emphasized.