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

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ClinicalTrials.gov Identifier: NCT03781115
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Sidney R. Baer, Jr. Foundation
Information provided by (Responsible Party):
University of Arizona

Brief 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.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Ziprasidone Drug: Olanzapine Drug: Placebo Comparator Phase 1

Detailed Description:

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 antipsychotic medications, which will be reflected in differences in the participants' electroencephalogram response (EEG), when compared to healthy control participants.The following Specific Aims are designed to test this hypothesis and create the diagnostic tool.

Specific Aim 1: The investigators will first conduct a pilot dose-response evaluation of the anti-psychotic drugs ziprasidone (Geodon) (20, 40, or 60 mg tablet) and olanzapine (Zyprexa®) (2.5, 5, 7.5, or 10 mg tablet) in non-psychiatric ill control participants to determine the optimal dosage that promotes sedation in healthy participants versus a placebo. The evaluation will comprise of a physical examination and questionnaires. The investigators will start with the lowest dose of each drug and if the dosage fails to induce sedation in healthy participants, the investigators will repeat the pilot dose-response evaluation with the next higher dose until the maximum dose is reached for both drugs. Specific Aim 2. To determine whether the pattern of EEG activity in response to a single dose of the anti-psychotic medication determined from the dose-response study from Aim 1 distinguishes schizophrenia participants from normal controls. The investigators will start with 2-4 healthy control participants to determine that the results show a discernible effect on the EEG using the dosage from Aim 1. If the dose of anti-psychotic medication fails to show an effect on the EEG the investigators will increase the dosage until the maximum dosage of the chosen medication is used. Once the dosage is identified the investigators will move onto getting IRB approval to evaluate participants diagnosed with schizophrenia.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators will first conduct a dose-response evaluation of the anti-psychotic drug ziprasidone (Geodon) (20, 40, or 60 mg tablet) or olanzapine (Zyprexa®) (2.5, 5, 7.5, or 10 mg tablet) in non-psychiatric ill control individuals to determine the dosage that promotes sedation in individuals versus a placebo. The evaluation will comprise of a physical examination, drug/pregnancy screenings and sleepiness questionnaires. Once the dosage of the anti-psychotic medication is determined new healthy subjects will be recruited to ingest the medication and have an electroencephalogram (EEG) recording taken. If the dosage of medication does not show an effect on the EEG the investigators will ask the individual to come back on a different day so the next higher dose of medication can be given. Once a the healthy subject's EEG shows an effect new control subjects and individuals with a diagnosis of schizophrenia will be recruited.
Masking: Double (Participant, Investigator)
Masking Description: Double Blind Masking: The participant and the investigator are both blinded.
Primary Purpose: Diagnostic
Official Title: Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
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.
Drug: Ziprasidone
anti-psychotic drug proposed for use as rapid diagnostic tool
Other Name: Geodon

Drug: Olanzapine
anti-psychotic drug proposed for use as rapid diagnostic tool
Other Name: Zyprexa

Drug: Placebo Comparator
A non drug oral placebo capsule will be given as a control
Other Name: Placebo Oral Capsule

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).
Drug: Olanzapine
anti-psychotic drug proposed for use as rapid diagnostic tool
Other Name: Zyprexa

Drug: Placebo Comparator
A non drug oral placebo capsule will be given as a control
Other Name: Placebo Oral Capsule

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.
Drug: Ziprasidone
anti-psychotic drug proposed for use as rapid diagnostic tool
Other Name: Geodon

Drug: Placebo Comparator
A non drug oral placebo capsule will be given as a control
Other Name: Placebo Oral Capsule




Primary Outcome Measures :
  1. Heart Rate [ Time Frame: up to 2 years ]
    Evaluating the heart rate of the subject every hour during all the test procedures

  2. Pulse Rate [ Time Frame: up to 2 years ]
    Evaluating the pulse rate of the subject every hour during all the test procedures

  3. Stanford Sleepiness Scale [ Time Frame: up to 2 years ]
    The subject will rate how sleepy they are feeling at baseline and every hour during the test using an (8) point scale (i.e. 1= feeling active, vital alert, or wide awake; 2= functioning at high levels, but not fully alert; 3= awake, but relaxed, responsive but not fully alert; 4= somewhat foggy, let down; 5= foggy, losing interest in remaining awake, slowed down; 6= sleepy, woozy, fighting sleep, prefer to lay down; 7= no longer fighting sleep, sleep onset soon, having dream-like thoughts; 8= asleep

  4. Epworth Sleepiness Scale [ Time Frame: up to 2 years ]
    The subject will rate their pre-test sleepiness only once during the test using a (4) point scale (0= no chance of dosing, 1= slight chance of dosing, 2= moderate chance of dozing and 3= high chance of dozing

  5. Fatigue Severity Scale [ Time Frame: up to 2 years ]
    The subject will rate their pre-test fatigue only once during the test by rating 10 questions using a slide scale between 1 and 7. A rating of 1 means the subject strongly disagrees with the statement. A rating of 7 means the subject strongly agrees with the statement.

  6. Chalder Fatigue Scale [ Time Frame: up to 2 years ]
    Subjects will rate their fatigue every hour and at baseline by answering 11 questions and rating their fatigue using a 4 point scale (i.e. less than usual, no more than usual, more than usual and much more than usual)

  7. Psychomotor physical computerized test [ Time Frame: up to 2 years ]
    The participants uses a computerized test to test their reflexes every hour and at baseline during the trial period. Every time a red dot appears in the middle of the screen the participant must touch the computer screen as fast as they can. This test was measured in how fast they responded (ms) and by how many attempts to touch the screen were recorded in 2 minutes

  8. Hand Fatigue Scale [ Time Frame: up to 2 years ]
    A hand grip measuring device will be used to test for fatigue. A small hand held device will measure the participants hand grip strength every hour during the test and at baseline.

  9. Electroencephalogram [ Time Frame: up to 2 years ]
    Electroencephalogram will be taken at baseline and after subjects have taken the anti-psychotic medication. There will be no placebo taken for this test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 teh 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781115


Contacts
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Contact: Janet Campbell, MS 602-827-2134 janetcampbell@email.arizona.edu
Contact: Amelia Gallitano, MD/PhD 6028272131 amelia@email.arizona.edu

Locations
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United States, Arizona
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
Banner University Medical Center Recruiting
Phoenix, Arizona, United States, 85006
Sub-Investigator: Steve Chung, MD         
Sponsors and Collaborators
University of Arizona
Sidney R. Baer, Jr. Foundation
Investigators
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Principal Investigator: Amelia Gallitano, MD,PhD University of Arizona College of Medicine

Publications:

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03781115     History of Changes
Other Study ID Numbers: 1612051594
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Arizona:
schizophrenia, psychosis, ziprasidone, olanzapine
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Ziprasidone
Antipsychotic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents