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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
University of Arizona
Study ID
NCT03781115
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Ziprasidone — DRUG
    anti-psychotic drug proposed for use as rapid diagnostic tool
  • Olanzapine — DRUG
    anti-psychotic drug proposed for use as rapid diagnostic tool
  • Placebo Comparator — DRUG
    A non drug oral placebo capsule will be given as a control

Study Details

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.

Key Dates

Start date
Nov 20, 2017
Status verified
May 2025
Primary completion
Feb 10, 2026
Completion
Feb 10, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Ziprasidone
    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.
  • Experimental: Olanzapine
    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).
  • Placebo Comparator: Placebo Comparator
    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.

Primary Outcome Measure

Heart Rate [ Time Frame: up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Banner University Medical CenterPhoenixArizona85006
Steve Chung, MD (SUB_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Banner University Medical Center· Phoenix, AZ

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