Prepulse Inhibition (PPI) of Startle Reflex in Schizophrenia Patients Related to Type of Treatment and Illness Duration

Study Overview
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Brief Summary
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PPI is an objective measure to assess pre-attentive processes that have already been tested before in the case of schizophrenia. The investigators aim to assess through this instrument two main characteristics, that the investigators assume are of relevance which are the duration of illness and the type of pharmaceutical treatment, patients receive. The investigators believe these two main characteristics are critical to the ability of the patients in improvement of their PPI response to startle reflex.

Detailed Description
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It is common to relate changes of PPI to startle reflex to both negative and positive signs of schizophrenia. Results can both start to explain formations of delusions and hallucinations and the difficulty in processing information for surrounding. It was already tested and discussed in previous trials the relation between type of pharmaceutical treatment as affecting on PPI to startle reflex both causing changes, or improving previous results. In previous trials as opposed to our planned trial, not much attention was paid for the relation on the changes found to the type of treatment and the duration of the illness. Plus, most trails had different methods of assessing it than our method. The investigators assume that patients who are receiving typical antipsychotic treatment would have a reduced PPI response to startle reflex compared with those with atypical antipsychotic treatment and those with longer duration of illness would also have reduced PPI response to startle reflex in comparison to those with shorted duration of illness. The investigators aim to enroll patients already diagnosed with schizophrenia that would be sent by their psychiatrist to the trial. In addition the investigators would enroll control group, not diagnosed with any psychiatric condition. For both groups, the investigators would run PPI trials according to a unified protocol. In addition the investigators would run several questionnaires for the group of the patients. Among the details asked of the patient are the duration of the illness and the type of antipsychotic medications they are on and the dosage. Data will then be analyzed.

Official Title
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Characteristics of Prepulse Inhibition (PPI) of Startle Reflex in Patients With Schizophrenia in Relation to Type of Pharmacological Treatment and Duration of Illness

Conditions
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Inhibition (Psychology), Schizophrenia, Medication Adherence

Intervention / Treatment
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* Device: PPI monitoring device protocol
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Patients diagnosed with schizophrenia Inclusion Criteria: Patients diagnosed with schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual (DSM) or International Classification of Diseases (ICD). Patients on antipsychotic medications either typical or atypical Patients older than 18 years old and younger than 90 years old In psychiatric follow-up Exclusion criteria: Patients with earing problems Patients who went through Invasive brain procedure Patients diagnosed with mental retardation Patients with psychoactive substances abuse Pregnant women Patients receiving or received electroconvulsive therapy Patients who have had any medication's regimen changes in either type or dosage in the last month before trial Patients on hormonal therapy Healthy subjects: Inclusion criteria: Subjects with no known psychiatric condition Subjects older than 18 years old and younger than 90 years old Exclusion Criteria: Subjects with earing problems Subjects who went through Invasive brain procedure Subjects diagnosed with mental retardation Subjects with psychoactive substances abuse Pregnant women Subjects on hormonal therapy Subjects with unstable physical status Subjects on psychoactive drug Subjects who have spent time abroad where there is at least 2 hours zone time difference from Israel

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Schizophrenia patients<br>Patients diagnosed with Schizophrenia. Will be assigned to PPI monitoring device protocol, according to unified protocol and have questionnaires to assess their status. | Device: PPI monitoring device protocol<br>* The investigators would use a monitoring device that would assess startle reflex reaction measured by blinking or the eye. Monitoring would be done with electrodes of EMG device that would be located on orbicularis oculi muscle and will monitor response.<br>Other: Questionnaires<br>* Group of patients diagnosed with schizophrenia would be interviewed using well validated questionnaires. Questionnaires what would be used are: GAF- Global assessment of functioning PANSS- Positive and negative syndrome scale SANS- Scale for the Assessment of Negative Symptoms The Calgary Depression Scale for schizophrenia Demographic Questionnaire Hamilton Anxiety scale<br>|
| Other: Healthy subject<br>This group would be assigned to PPI monitoring device protocol, according to a unified protocol similar to group of patients but not to questionnaires. | Device: PPI monitoring device protocol<br>* The investigators would use a monitoring device that would assess startle reflex reaction measured by blinking or the eye. Monitoring would be done with electrodes of EMG device that would be located on orbicularis oculi muscle and will monitor response.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Startle reflex response (anxiety) | Assessed by millivolts registered by electromyography (EMG) electrodes | 2 hours from arriving to hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prepulse inhibition response (sensorimotor gating) | Assessed by millivolts registered by EMG electrodes | 2 hours from arriving to the hospital during the time of monitoring | 
| Duration of illness | Illness duration of longer than 5 years will be considered long illness duration while shorter duration than 5 years will be considered short illness duration those will then be compared with results of startle and PPI results | 4 hours from arriving to the hospital, during questionnaires parts | 
| Type or class of antipsychotic agents | According to response in demographic questionnaire, a further subdivision of either Typical or Atypical antipsychotic agent to then be compared with results of startle and PPI results | 4 hours from arriving to the hospital during questionnaires parts |