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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• Be between 18 and 40 years of age

• Be able to understand English

• Have no history of psychosis

• Have no history of sleep apnea, heart condition or seizure

• Have no known drug allergies

• The ability to swallow a pill

• Be between 18 and 40 years of age

• Be able to understand English

• Have been diagnosed with a Schizophrenia Spectrum or other psychotic disorder

• Belong to one of three groups:

‣ Never medicated patients with a first episode of psychosis

⁃ Have not received long acting injectable (depot) antipsychotic in previous 6 months

⁃ Have not received oral antipsychotic (or antidepressant that has serotonergic action) in previous 2 weeks

• Have no history of sleep apnea, heart condition or seizure

• Have no known drug allergies

• Be able to swallow a pill

• Healthy as determined by the enrolling physician(s)

Locations
United States
Arizona
Banner University Medical Center
RECRUITING
Phoenix
Contact Information
Primary
Janet Campbell, MS
janetcampbell@email.arizona.edu
602-827-2875
Backup
Amelia Gallitano, MD/PhD
amelia@email.arizona.edu
6028272131
Time Frame
Start Date: 2017-11-20
Estimated Completion Date: 2026-02-10
Participants
Target number of participants: 24
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Sidney R. Baer, Jr. Foundation
Leads: University of Arizona

This content was sourced from clinicaltrials.gov