Rapid, low-cost diagnostic test for schizophrenia using drug-challenge EEG
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
This project will try whether a brief EEG taken after a small dose of an antipsychotic can help diagnose schizophrenia in adults aged 18–40.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT03781115 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional project uses a drug-challenge approach and EEG to search for a diagnostic signature of schizophrenia. Investigators will first do a pilot dose-response in healthy control participants to find doses of ziprasidone and olanzapine that reliably produce sedation compared with placebo. They will then give a single dose at the selected level to people with schizophrenia and to controls while recording EEG to compare brain-wave responses. The aim is to identify a reproducible EEG pattern that distinguishes schizophrenia patients from healthy participants and could form the basis of a rapid, inexpensive diagnostic tool.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults 18–40 with a diagnosed schizophrenia-spectrum or other psychotic disorder who meet the study's medication-history criteria (for example, first-episode never-medicated patients or those without recent depot or oral antipsychotic use).
Not a fit: People outside the 18–40 age range, those with seizure disorder, significant heart problems, sleep apnea, positive drug screens, pregnancy, or recent antipsychotic exposure are unlikely to be eligible or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a fast, inexpensive diagnostic test that helps identify schizophrenia by measuring EEG responses to a brief antipsychotic challenge.
How similar studies have performed: While EEG biomarker research in schizophrenia exists, using antipsychotic-induced sedation patterns as a diagnostic test is largely novel and has limited prior clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Healthy Control 1. Be between 18 and 40 years of age 2. Be able to understand English 3. Have no history of psychosis 4. Have no history of sleep apnea, heart condition or seizure 5. Have no known drug allergies 6. The ability to swallow a pill Exclusion Criteria Healthy control 1. Refuse to sign the consent form 2. Drink caffeine or alcohol within 24 hours of the study 3. Have the EKG readout report borderline or abnormal ECG 4. Have the 12 panel urine drug screen show a positive result 5. Be pregnant Inclusion Criteria Schizophrenic subject 1. Be between 18 and 40 years of age 2. Be able to understand English 3. Have been diagnosed with a Schizophrenia Spectrum or other psychotic disorder 4. Belong to one of three groups: 1. Never medicated patients with a first episode of psychosis 2. Have not received long acting injectable (depot) antipsychotic in previous 6 months 3. Have not received oral antipsychotic (or antidepressant that has serotonergic action) in previous 2 weeks 5. Have no history of sleep apnea, heart condition or seizure 6. Have no known drug allergies 7. Be able to swallow a pill 8. Healthy as determined by the enrolling physician(s) Exclusion Criteria Schizophrenic subject 1. Refuse to sign the consent form 2. Drink caffeine or alcohol within 24 hours of the study 3. Have the EKG readout report borderline or abnormal ECG 4. Have the 12 panel urine drug screen show a positive result 5. Be pregnant
Where this trial is running
Phoenix, Arizona
- Banner University Medical Center — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Amelia Gallitano, MD,PhD — University of Arizona College of Medicine
- Study coordinator: Janet Campbell, MS
- Email: janetcampbell@email.arizona.edu
- Phone: 602-827-2875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.