Schizophrenia Clinical Trial
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
NCT number | NCT02484521 |
Other study ID # | 0050-15-EMC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | June 2019 |
Verified date | September 2017 |
Source | HaEmek Medical Center, Israel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Haemek Medical Center | `Afula |
Lead Sponsor | Collaborator |
---|---|
HaEmek Medical Center, Israel |
Israel,
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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation
Kohl S, Heekeren K, Klosterkötter 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. Review. — View 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. Epub 2002 Jun 5. Review. — View 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. — View 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. Erratum in: Arch Gen Psychiatry. 2007 Mar;64(3):360. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Startle reflex response (anxiety) | Assessed by millivolts registered by electromyography (EMG) electrodes | 2 hours from arriving to hospital | |
Secondary | Prepulse inhibition response (sensorimotor gating) | Assessed by millivolts registered by EMG electrodes | 2 hours from arriving to the hospital during the time of monitoring | |
Secondary | 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 | 4 hours from arriving to the hospital, during questionnaires parts | |
Secondary | 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 | 4 hours from arriving to the hospital during questionnaires parts |
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