RecruitingPhase 1NCT03781115

Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia


Sponsor

University of Arizona

Enrollment

24 participants

Start Date

Nov 20, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

Schizophrenia is a severe psychotic illness of unknown cause that affects 1% of the population worldwide. Currently, there is no diagnostic test for schizophrenia. Instead, the diagnosis is typically established through a psychiatric interview of the patient, who is evaluated against a set of established criteria of signs and symptoms. It can take many months to years to establish a diagnosis of schizophrenia and achieve an appropriate treatment regimen to attain resolution of the patient's symptoms. This process is particularly challenging in areas of limited access to specialists a problem not only in third world countries and rural regions, but throughout the United States where there can be long waits to obtain an appointment with a psychiatrist. The present research experiment investigates a potential novel method for diagnosing schizophrenia. The overall objective of the study is to test the hypothesis that patients with schizophrenia will have a heightened tolerance to the sedating effects of anti-psychotic medications, which will be reflected in differences in their electroencephalogram (EEG) when compared to healthy normal controls. The investigators expect that the schizophrenia patients will score on the "more alert" and "less sleepy" ends of these scales, and that the normal control subjects will show the opposite response. A patient that fails to become sedated or experience the sleepiness side effects, typically caused by the anti-psychotic medication, may support the existing diagnosis of schizophrenia. Measures of the subjects' level of sedation that are found to correlate significantly with EEG response and diagnosis will be used to create a diagnostic test. This simple and inexpensive test will consist of a single dosage of anti-psychotic medication, and a rapid assessment tool with scores that have a high degree of predictive validity for the diagnosis of schizophrenia.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is working to develop a quick, affordable blood or saliva test that could help diagnose schizophrenia, a serious mental health condition that affects how a person thinks, feels, and behaves. Currently, diagnosis relies entirely on observation of symptoms, which can take a long time. The study is enrolling both healthy volunteers and people with schizophrenia to compare specific biological signals between the groups, with the hope of finding reliable markers that distinguish the two — potentially speeding up diagnosis and opening new treatment approaches. **You may be eligible if you are a healthy volunteer and...** - You are between 18 and 40 years old - You can understand English - You have no history of psychosis, sleep apnea, heart conditions, or seizures - You have no known drug allergies and are able to swallow a pill **You may NOT be eligible if...** - You have a personal history of psychosis or a diagnosed mental health disorder - You have a heart condition, seizure disorder, or sleep apnea - You have known drug allergies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZiprasidone

anti-psychotic drug proposed for use as rapid diagnostic tool

DRUGOlanzapine

anti-psychotic drug proposed for use as rapid diagnostic tool

DRUGPlacebo Comparator

A non drug oral placebo capsule will be given as a control


Locations(1)

Banner University Medical Center

Phoenix, Arizona, United States

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NCT03781115


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