An interventional study of PPI monitoring device protocol and Questionnaires in Inhibition (Psychology), Schizophrenia and Medication Adherence, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Basic science
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with schizophrenia
Inclusion Criteria:
Exclusion criteria:
Healthy subjects:
Inclusion criteria:
Exclusion Criteria:
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 · Other: Questionnaires
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
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.
Group of patients diagnosed with schizophrenia would be interviewed using well validated questionnaires. Questionnaires what would be used are: 1. GAF- Global assessment of functioning 2. PANSS- Positive and negative syndrome scale 3. SANS- Scale for the Assessment of Negative Symptoms 4. The Calgary Depression Scale for schizophrenia 5. Demographic Questionnaire 6. Hamilton Anxiety scale
Startle reflex response (anxiety)
Assessed by millivolts registered by electromyography (EMG) electrodes
Time frame: 2 hours from arriving to hospital
Prepulse inhibition response (sensorimotor gating)
Assessed by millivolts registered by EMG electrodes
Time frame: 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
Time frame: 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
Time frame: 4 hours from arriving to the hospital during questionnaires parts
Plan to share: No
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel