search
Back to results

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

Primary Purpose

Inhibition (Psychology), Schizophrenia, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PPI monitoring device protocol
Questionnaires
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inhibition (Psychology)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Haemek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Schizophrenia patients

Healthy subject

Arm Description

Patients diagnosed with Schizophrenia. Will be assigned to PPI monitoring device protocol, according to unified protocol and have questionnaires to assess their status.

This group would be assigned to PPI monitoring device protocol, according to a unified protocol similar to group of patients but not to questionnaires.

Outcomes

Primary Outcome Measures

Startle reflex response (anxiety)
Assessed by millivolts registered by electromyography (EMG) electrodes

Secondary Outcome Measures

Prepulse inhibition response (sensorimotor gating)
Assessed by millivolts registered by EMG electrodes
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
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

Full Information

First Posted
June 13, 2015
Last Updated
February 12, 2020
Sponsor
HaEmek Medical Center, Israel
search

1. Study Identification

Unique Protocol Identification Number
NCT02484521
Brief Title
Prepulse Inhibition (PPI) of Startle Reflex in Schizophrenia Patients Related to Type of Treatment and Illness Duration
Official Title
Characteristics of Prepulse Inhibition (PPI) of Startle Reflex in Patients With Schizophrenia in Relation to Type of Pharmacological Treatment and Duration of Illness
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhibition (Psychology), Schizophrenia, Medication Adherence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schizophrenia patients
Arm Type
Active Comparator
Arm Description
Patients diagnosed with Schizophrenia. Will be assigned to PPI monitoring device protocol, according to unified protocol and have questionnaires to assess their status.
Arm Title
Healthy subject
Arm Type
Other
Arm Description
This group would be assigned to PPI monitoring device protocol, according to a unified protocol similar to group of patients but not to questionnaires.
Intervention Type
Device
Intervention Name(s)
PPI monitoring device protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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
Primary Outcome Measure Information:
Title
Startle reflex response (anxiety)
Description
Assessed by millivolts registered by electromyography (EMG) electrodes
Time Frame
2 hours from arriving to hospital
Secondary Outcome Measure Information:
Title
Prepulse inhibition response (sensorimotor gating)
Description
Assessed by millivolts registered by EMG electrodes
Time Frame
2 hours from arriving to the hospital during the time of monitoring
Title
Duration of illness
Description
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
Title
Type or class of antipsychotic agents
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
elad kurante, MD
Organizational Affiliation
haemek MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek Medical Center
City
'Afula
ZIP/Postal Code
18101
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11549226
Citation
Braff DL, Geyer MA, Swerdlow NR. Human studies of prepulse inhibition of startle: normal subjects, patient groups, and pharmacological studies. Psychopharmacology (Berl). 2001 Jul;156(2-3):234-58. doi: 10.1007/s002130100810.
Results Reference
background
PubMed Identifier
23287742
Citation
Kohl S, Heekeren K, Klosterkotter J, Kuhn J. Prepulse inhibition in psychiatric disorders--apart from schizophrenia. J Psychiatr Res. 2013 Apr;47(4):445-52. doi: 10.1016/j.jpsychires.2012.11.018. Epub 2013 Jan 1.
Results Reference
background
PubMed Identifier
15306146
Citation
Perry W, Minassian A, Feifel D. Prepulse inhibition in patients with non-psychotic major depressive disorder. J Affect Disord. 2004 Aug;81(2):179-84. doi: 10.1016/S0165-0327(03)00157-5.
Results Reference
background
PubMed Identifier
11549216
Citation
Geyer MA, Krebs-Thomson K, Braff DL, Swerdlow NR. Pharmacological studies of prepulse inhibition models of sensorimotor gating deficits in schizophrenia: a decade in review. Psychopharmacology (Berl). 2001 Jul;156(2-3):117-54. doi: 10.1007/s002130100811.
Results Reference
background
PubMed Identifier
12110987
Citation
Kumari V, Sharma T. Effects of typical and atypical antipsychotics on prepulse inhibition in schizophrenia: a critical evaluation of current evidence and directions for future research. Psychopharmacology (Berl). 2002 Jul;162(2):97-101. doi: 10.1007/s00213-002-1099-x. Epub 2002 Jun 5.
Results Reference
background
PubMed Identifier
20177883
Citation
Kishi T, Moriwaki M, Kitajima T, Kawashima K, Okochi T, Fukuo Y, Furukawa O, Naitoh H, Fujita K, Iwata N. Effect of aripiprazole, risperidone, and olanzapine on the acoustic startle response in Japanese chronic schizophrenia. Psychopharmacology (Berl). 2010 Apr;209(2):185-90. doi: 10.1007/s00213-010-1787-x. Epub 2010 Feb 23.
Results Reference
background
PubMed Identifier
20633319
Citation
Aggernaes B, Glenthoj BY, Ebdrup BH, Rasmussen H, Lublin H, Oranje B. Sensorimotor gating and habituation in antipsychotic-naive, first-episode schizophrenia patients before and after 6 months' treatment with quetiapine. Int J Neuropsychopharmacol. 2010 Nov;13(10):1383-95. doi: 10.1017/S1461145710000787. Epub 2010 Jul 16.
Results Reference
background
PubMed Identifier
17146007
Citation
Swerdlow NR, Light GA, Cadenhead KS, Sprock J, Hsieh MH, Braff DL. Startle gating deficits in a large cohort of patients with schizophrenia: relationship to medications, symptoms, neurocognition, and level of function. Arch Gen Psychiatry. 2006 Dec;63(12):1325-35. doi: 10.1001/archpsyc.63.12.1325. Erratum In: Arch Gen Psychiatry. 2007 Mar;64(3):360.
Results Reference
background
PubMed Identifier
24801767
Citation
Csomor PA, Preller KH, Geyer MA, Studerus E, Huber T, Vollenweider FX. Influence of aripiprazole, risperidone, and amisulpride on sensory and sensorimotor gating in healthy 'low and high gating' humans and relation to psychometry. Neuropsychopharmacology. 2014 Sep;39(10):2485-96. doi: 10.1038/npp.2014.102. Epub 2014 May 7.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs