Inhibition (Psychology)NCT02484521
Prepulse Inhibition (PPI) of Startle Reflex in Schizophrenia Patients Related to Type of Treatment and Illness Duration
A study testing PPI monitoring device protocol and Questionnaires in people with Inhibition (Psychology) and Schizophrenia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Inhibition (Psychology), Schizophrenia, Medication Adherence
- What is being tested?
- PPI monitoring device protocol and Questionnaires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Subjects with no known psychiatric condition
- Subjects older than 18 years old and younger than 90 years old
Who cannot join
- 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
Show all 18Show fewer
- 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 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Inhibition (Psychology), Schizophrenia, Medication Adherence
- Being tested
- PPI monitoring device protocol, Questionnaires
- Medical subject headings
- Inhibition, Psychological, Schizophrenia, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI monitoring device protocolDevice
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.
QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: PPI monitoring device protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Startle reflex response (anxiety)
Assessed by millivolts registered by electromyography (EMG) electrodes
Measured: 2 hours from arriving to hospital
Secondary outcomes (3)
Prepulse inhibition response (sensorimotor gating)
Assessed by millivolts registered by EMG electrodes
Measured: 2 hours from arriving to the hospital during the time of monitoring
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
Measured: 4 hours from arriving to the hospital, during questionnaires parts
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
Measured: 4 hours from arriving to the hospital during questionnaires parts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Inhibition (Psychology)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elad Haim Kurant, HaEmek Medical Center, Israel
- Investigators
- elad kurante, MD, Principal investigator, haemek MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484521
- Sponsor's protocol ID
- 0050-15-EMC
- Status last verified
- Sep 2017
- First submitted
- 13 Jun 2015
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 11549226Kohl 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.
PubMed 23287742Perry 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.
PubMed 15306146Geyer 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.
PubMed 11549216Kumari 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.
PubMed 12110987Kishi 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.
PubMed 20177883Aggernaes 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.
PubMed 20633319Swerdlow 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.
PubMed 17146007Csomor 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.
PubMed 24801767
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02484521
- Acronym / sponsor ID
- 0050-15-EMC
- Conditions
- Inhibition (Psychology), Schizophrenia, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia patients | Active comparator | Device: PPI monitoring device protocol, Other: QuestionnairesPatients diagnosed with Schizophrenia. Will be assigned to PPI monitoring device protocol, according to unified protocol and have questionnaires to assess their status. |
| Healthy subject | Other | Device: PPI monitoring device protocolThis group would be assigned to PPI monitoring device protocol, according to a unified protocol similar to group of patients but not to questionnaires. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Subjects with no known psychiatric condition
Key exclusion criteria (18 listed)
- Patients with earing problems
- Patients who went through Invasive brain procedure
- Patients diagnosed with mental retardation
- Patients with psychoactive substances abuse
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI monitoring device protocolThe 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. | Device | Healthy subject, Schizophrenia patients |
| QuestionnairesGroup 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 | Schizophrenia patients |
Primary outcome
Startle reflex response (anxiety)
Time frame: 2 hours from arriving to hospital
Assessed by millivolts registered by electromyography (EMG) electrodes
3 secondary outcomes
Prepulse inhibition response (sensorimotor gating)
Time frame: 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
Type or class of antipsychotic agents
Time frame: 4 hours from arriving to the hospital during questionnaires parts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 11549226Braff 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.
- Background: PubMed 23287742Kohl 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.
- Background: PubMed 15306146Perry 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.
- Background: PubMed 11549216Geyer 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.
- Background: PubMed 12110987Kumari 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.
- Background: PubMed 20177883Kishi 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.
- Background: PubMed 20633319Aggernaes 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.
- Background: PubMed 17146007Swerdlow 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.
- Background: PubMed 24801767Csomor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
elad kurante, MD principal investigator
haemek MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI monitoring device protocol and Questionnaires in people with Inhibition (Psychology) and Schizophrenia, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Startle reflex response (anxiety) (time frame: 2 hours from arriving to hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484521, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.