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

NCT02484521 | Completed DMC

• 1 other identifier: 0050-15-EMC
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Inhibition (Psychology); Schizophrenia; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Startle reflex response (anxiety)

  Assessed by millivolts registered by electromyography (EMG) electrodes

  2 hours from arriving to hospital

Secondary Outcomes (3)

• Prepulse inhibition response (sensorimotor gating)

  2 hours from arriving to the hospital during the time of monitoring

• Duration of illness

  4 hours from arriving to the hospital, during questionnaires parts

• Type or class of antipsychotic agents

  4 hours from arriving to the hospital during questionnaires parts

Study Arms (2)

Schizophrenia patients

ACTIVE COMPARATOR

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

Healthy subject

OTHER

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

Interventions

PPI monitoring device protocol DEVICE

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.

Healthy subject; Schizophrenia patients

Questionnaires OTHER

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

Schizophrenia patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Subjects with no known psychiatric condition
• Subjects older than 18 years old and younger than 90 years old
• Subjects with earing problems
• Subjects who went through Invasive brain procedure
• Subjects diagnosed with mental retardation
• Subjects with psychoactive substances abuse

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, 18101, Israel

Location

Related Publications (9)

• 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.

  PMID: 11549226 BACKGROUND

• 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.

  PMID: 23287742 BACKGROUND

• 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.

  PMID: 15306146 BACKGROUND

• 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.

  PMID: 11549216 BACKGROUND

• 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.

  PMID: 12110987 BACKGROUND

• 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.

  PMID: 20177883 BACKGROUND

• 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.

  PMID: 20633319 BACKGROUND

• 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.

  PMID: 17146007 BACKGROUND

• 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.

  PMID: 24801767 BACKGROUND

MeSH Terms

Conditions

Inhibition, Psychological; Schizophrenia; Medication Adherence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• elad kurante, MD

  haemek MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatry resident

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: June 29, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 13, 2020

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)