Prepulse Inhibition (PPI) of Startle Reflex in Schizophrenia Patients Related to Type of Treatment and Illness Duration
NCT ID: NCT02484521
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2015-06-30
2019-06-30
Brief Summary
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The investigators believe these two main characteristics are critical to the ability of the patients in improvement of their PPI response to startle reflex.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
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.
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
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.
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.
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
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
1. Subjects with no known psychiatric condition
2. Subjects older than 18 years old and younger than 90 years old
Exclusion Criteria
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:
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
18 Years
90 Years
ALL
Yes
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Elad Haim Kurant
Psychiatry resident
Principal Investigators
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elad kurante, MD
Role: PRINCIPAL_INVESTIGATOR
haemek MC
Locations
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Haemek Medical Center
Afula, , Israel
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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0050-15-EMC
Identifier Type: -
Identifier Source: org_study_id
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