Diagnostic Test for Schizophrenia

Recruiting at 1 trial location

Overseen By Amelia Gallitano, MD/PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Arizona

Must not be taking: Antidepressants

Disqualifiers: Psychosis, Sleep apnea, Heart condition, others

Compensation: Varies

Number of Visits: 1

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to diagnose schizophrenia, a serious mental illness, by observing reactions to antipsychotic drugs. Researchers believe that individuals with schizophrenia might not experience as much drowsiness after taking these drugs, unlike those without the condition. The study involves administering a dose of either Olanzapine or Ziprasidone and measuring brain activity to determine if this can aid in confirming a diagnosis. Healthy individuals with no history of psychosis and those recently diagnosed with schizophrenia who have not been heavily medicated are suitable candidates for participation. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Do I need to stop my current medications to join the trial?

Yes, if you are taking oral antipsychotics or antidepressants with serotonergic action, you must stop them at least 2 weeks before joining the trial. If you are on long-acting injectable antipsychotics, you must not have received them in the past 6 months.

What prior data suggests that this diagnostic method is safe?

Previous studies have shown that olanzapine is generally safe. People taking olanzapine often experience mild to moderate side effects, such as drowsiness and weight gain, while serious reactions remain rare. Olanzapine is a well-known treatment for schizophrenia and is considered safe when used as directed.

Research on ziprasidone indicates it is usually safe and well-tolerated for short periods, such as four weeks. Most people do not encounter new or unexpected safety issues, though there is a rare risk of serious skin reactions.

Both olanzapine and ziprasidone are established treatments for mental health conditions, and their safety is well understood. Participants in studies have generally tolerated these medications, though, as with any medication, some risks of side effects exist. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential for using olanzapine and ziprasidone in a new way to diagnose schizophrenia. Unlike traditional approaches that focus on symptom management, this trial aims to see how these medications can be used to achieve a desired sedation effect and then measure brain activity with an EEG. This could lead to a novel diagnostic method that provides insights into the brain's response to these medications, potentially identifying schizophrenia more effectively and earlier. By understanding the brain's reaction, researchers hope to pave the way for more personalized treatment plans in the future.

What evidence suggests that this method is effective for diagnosing schizophrenia?

In this trial, participants will receive either olanzapine or ziprasidone. Studies have shown both medications effectively treat symptoms of schizophrenia. Olanzapine significantly reduces a wide range of symptoms and improves social interactions. Research indicates it also helps prevent symptoms from returning after improvement. Ziprasidone has proven more effective than a placebo in reducing psychotic symptoms and lowering the chance of recurrence. It excels in managing the severity and duration of symptoms. Both medications have a strong track record in aiding individuals with schizophrenia, supporting their potential use in understanding the condition based on patient responses. ^{5 6 7 8 9}

Who Is on the Research Team?

Amelia Gallitano, MD,PhD

Principal Investigator

University of Arizona College of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals who can understand English, have no history of psychosis or sleep apnea, heart conditions, seizures, and no known drug allergies. Participants must be able to swallow a pill but cannot already be diagnosed with schizophrenia.

Inclusion Criteria

Schizophrenic Subject: Be able to understand English

Schizophrenic Subject: Have no known drug allergies

Schizophrenic Subject: Healthy as determined by the enrolling physician(s)

Exclusion Criteria

Healthy Control: Refuse to sign the consent form

Healthy Control: Be pregnant

Healthy Control: Drink caffeine or alcohol within 24 hours of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Dose-Response Evaluation

Conduct a pilot dose-response evaluation of anti-psychotic drugs in non-psychiatric control participants to determine optimal dosage for sedation.

4-8 weeks

Multiple visits for dose adjustments and assessments

EEG Evaluation

Evaluate EEG response to a single dose of anti-psychotic medication in schizophrenia participants and healthy controls.

4-6 weeks

1 visit for EEG assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Olanzapine
• Placebo Comparator
• Ziprasidone

Trial Overview The study aims to develop a quick and affordable diagnostic test for schizophrenia using EEG responses after administering anti-psychotic medications like Olanzapine or Ziprasidone versus a placebo.

How Is the Trial Designed?

Group I: Ziprasidone Experimental Treatment 3 Interventions

The investigators will conduct a pilot dose-response evaluation of a single dose of the anti-psychotic drug ziprasidone (Geodon). The investigators will start with a single 20mg pill given to (3) subjects and will increase the dosage in sequential subjects until the desired sedation effect is achieved (i.e. 40 and 60mg tablets). If Ziprasidone causes the desired sedation effect additional healthy subjects will be recruited to take the medication and have an electroencephalogram (EEG) taken.

Group II: Olanzapine Experimental Treatment 2 Interventions

The investigators will conduct a pilot dose-response evaluation of a single dose of the anti-psychotic drug olanzapine (Zyprexa). The investigators will start with a single 2.5 mg pill given to (3) subjects and will increase the dosage in sequential subjects until the desired sedation effect is achieved (i.e. 5, 7.5, and 10 mg tablets).If olanzapine causes the desired sedation effect additional healthy subjects will be recruited to take the medication and have an electroencephalogram (EEG).

Group III: Placebo Comparator Placebo Group 2 Interventions

The investigators have prepared a placebo which duplicates the exact color and size of the study drug capsule to use as a non-drug control.

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?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Sidney R. Baer, Jr. Foundation

Collaborator

Trials

3

Recruited

60+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6733343/

A commentary on the efficacy of olanzapine for the treatment ... The long-term effectiveness of olanzapine has been established across a number of long-term outcome domains, including relapse prevention ( ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883941724002280

Efficacy and safety evaluation of olanzapine treatment for ... Olanzapine demonstrated significant efficacy in reducing a wide range of schizophrenia symptoms, improving clinical status, enhancing social functioning,

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39955141/

Efficacy and safety evaluation of olanzapine treatment for ... Olanzapine demonstrated significant efficacy in reducing a wide range of schizophrenia symptoms, improving clinical status, enhancing social functioning, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824666

Comparative Effectiveness of Antipsychotics in Patients ... In this study, we compared the effectiveness of antipsychotics for relapse and treatment failure prevention compared with oral olanzapine, the ...

5. cell.com cell.com/heliyon/fulltext/S2405-8440(24)16455-9

Metabolic effects and clinical outcomes of olanzapine in ... The results showed that patients receiving olanzapine had significant weight gain (WMD = 0.25, 95 % CI: 0.06–0.44) and no significant changes in HDL-C, LDL-C, ...

6. uspharmacist.com uspharmacist.com/article/safety-data-support-first-olanzapine-option-for-schizophrenia

Safety Data Support First Olanzapine Option for ... Dr. Correll added, “Olanzapine is a long-established treatment option for schizophrenia with a well-known safety and efficacy profile, and ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9265911/

Safety of olanzapine The overall discontinuation rate from olanzapine treatment was low. Significant adverse events included somnolence, weight gain, and asymptomatic treatment- ...

8. tevausa.com tevausa.com/news-and-media/press-releases/new-long-term-safety-data-from-the-completed-phase-3-solaris-trial-support-the-potential-of-olanzapine-la/

New Long-term Safety Data from the Completed Phase 3 ... “Olanzapine is a long-established treatment option for schizophrenia with a well-known safety and efficacy profile, and olanzapine LAI (TEV ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf

ZYPREXA (olanzapine) Label - accessdata.fda.gov Olanzapine Monotherapy in Adolescents — The safety and efficacy of olanzapine have not been established in patients under the age of 13 years. In an analysis of ...