Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 12/21/2018 |
| Start Date: | December 2018 |
| End Date: | July 2020 |
| Contact: | Amelia Galliano, MD/PhD |
| Email: | amelia@email.arizona.edu |
| Phone: | 602-827-2131 |
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.
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.
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.
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.
Inclusion Criteria
1. Healthy non-psychiatrically ill, as determined by a brief medical history interview by
the enrolling research coordinator
2. No history, or current diagnosis, of sleep apnea, heart abnormalities, or seizure
3. Negative drug screen and pregnancy test
4. Satisfactory EKG test as determined by physician
5. Between the ages of 18 and 35
6. Ability to read and understand English
7. Abstinence from alcohol for 24 hours, and from illicit drugs for 2 weeks, prior to,
and 24 hours following, the study.
8. Subjects not taking any drug that prolong the QT interval (dofetilide, sotalol,
quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine,
chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin,
halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate,
dolasetron mesylate, probucol or tacrolimus).
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