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NCT03781115 · ClinicalTrials.gov registry record · Phase 1
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
A Phase 1 study of Schizophrenia, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03781115: Recruiting Phase 1 study of Schizophrenia, sponsored by University of Arizona.
NCT03781115 is a Phase 1 study of Schizophrenia that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 24 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03781115, a Phase 1 study of Schizophrenia, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Evaluating the heart rate of the subject every hour during all the test procedures
Conditions Studied
Interventions
- DRUG Placebo Comparator
- DRUG Olanzapine
- DRUG Ziprasidone
Study Locations (1)
Arizona
- Banner University Medical Center - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-11-20 |
| Est. Completion | 2026-02-10 |
| Phase | Phase 1 |
What NCT03781115 shows while recruiting
NCT03781115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Placebo Comparator is the first listed.
NCT03781115 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03781115 about?
NCT03781115 is a clinical study titled "Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia". 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 establ...
What is the current status of trial NCT03781115?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-11-20. Estimated completion is 2026-02-10.
What conditions does trial NCT03781115 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT03781115?
The interventions under investigation include: Placebo Comparator (DRUG), Olanzapine (DRUG), Ziprasidone (DRUG).
Who is sponsoring clinical trial NCT03781115?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03781115 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03781115's enrollment target sits among peer trials
24 276th of 315 higher than 36 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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