Actively Recruiting

Phase 1
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT03781115

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

Led by University of Arizona · Updated on 2025-06-03

24

Participants Needed

1

Research Sites

429 weeks

Total Duration

On this page

Sponsors

U

University of Arizona

Lead Sponsor

S

Sidney R. Baer, Jr. Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 18 and 40 years of age
  • Be able to understand English
  • Have no history of psychosis (healthy controls only)
  • Have been diagnosed with a Schizophrenia Spectrum or other psychotic disorder (schizophrenic subjects only)
  • For schizophrenic subjects, belong to one of three groups: never medicated first episode, no long acting injectable antipsychotic in past 6 months, or no oral antipsychotic/serotonergic antidepressant in past 2 weeks
  • Have no history of sleep apnea, heart condition, or seizure
  • Have no known drug allergies
  • Be able to swallow a pill
  • Be healthy as determined by the enrolling physician(s) (schizophrenic subjects only)
Not Eligible

You will not qualify if you...

  • Refuse to sign the consent form
  • Drink caffeine or alcohol within 24 hours of the study
  • Have borderline or abnormal ECG on EKG readout
  • Have a positive result on 12 panel urine drug screen
  • Be pregnant

AI-Screening

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Trial Site Locations

Total: 1 location

1

Banner University Medical Center

Phoenix, Arizona, United States, 85006

Actively Recruiting

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Research Team

J

Janet Campbell, MS

CONTACT

A

Amelia Gallitano, MD/PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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