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

February 12, 2020 updated by: Elad Haim Kurant, HaEmek Medical Center, Israel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • 'Afula, Israel, 18101
        • Haemek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients diagnosed with schizophrenia

Inclusion Criteria:

  1. Patients diagnosed with schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual (DSM) or International Classification of Diseases (ICD).
  2. Patients on antipsychotic medications either typical or atypical
  3. Patients older than 18 years old and younger than 90 years old
  4. In psychiatric follow-up

Exclusion criteria:

  1. Patients with earing problems
  2. Patients who went through Invasive brain procedure
  3. Patients diagnosed with mental retardation
  4. Patients with psychoactive substances abuse
  5. Pregnant women
  6. Patients receiving or received electroconvulsive therapy
  7. Patients who have had any medication's regimen changes in either type or dosage in the last month before trial
  8. Patients on hormonal therapy

Healthy subjects:

Inclusion criteria:

  1. Subjects with no known psychiatric condition
  2. Subjects older than 18 years old and younger than 90 years old

Exclusion Criteria:

  1. Subjects with earing problems
  2. Subjects who went through Invasive brain procedure
  3. Subjects diagnosed with mental retardation
  4. Subjects with psychoactive substances abuse
  5. Pregnant women
  6. Subjects on hormonal therapy
  7. Subjects with unstable physical status
  8. Subjects on psychoactive drug
  9. Subjects who have spent time abroad where there is at least 2 hours zone time difference from Israel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Schizophrenia patients
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
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.
Other: Questionnaires

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
Other: Healthy subject
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Startle reflex response (anxiety)
Time Frame: 2 hours from arriving to hospital
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)
Time Frame: 2 hours from arriving to the hospital during the time of monitoring
Assessed by millivolts registered by EMG electrodes
2 hours from arriving to the hospital during the time of monitoring
Duration of illness
Time Frame: 4 hours from arriving to the hospital, during questionnaires parts
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
Time Frame: 4 hours from arriving to the hospital during questionnaires parts
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: elad kurante, MD, HaEmek MC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

June 13, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0050-15-EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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