Sensitivity, Threshold, Tolerance and Pain Recognition in Schizophrenia Patients and Their Relatives.
1 other identifier
interventional
200
1 country
1
Brief Summary
It has been known that schizophrenia patients have a reduced ability to recognize both their own pain and the pain of others. The patients' pain judgement is not correlated with their affective or cognitive empathic capacities. These results suggest that changes in pain recognition in schizophrenia patients reflect specific dysfunctions in pain processing . Schizophrenia patients have a reduced ability to recognize both their own pain. This deficit is not related to their empathic capacities . The correlation between pain perception in schizophrenia patients and their ability to evaluate their own pain is still unknown. Pain insensitivity to pressure has been described in the context of schizophrenic illness was also evident in the biological relatives of those with the disorder. It is still unclear whether relatives of schizophrenia patients have aberrations in assessing their own pain in different imaginary situations. Animal models are important tools in the study of psychiatric disorders and the mechanism of action of antipsychotic and other psychiatric drugs. Positive symptoms of schizophrenia are difficult to model in rodents, but locomotor hyperactivity in response to a novel environment were reported as correlated with positive symptoms . On the other hand, negative symptoms such as social interaction and anhedonia and cognitive processing (e.g. emotional memory, sensorimotor gating, and associative learning) can be investigated in animal models with a high degree of validity . Furthermore, in most schizophrenia-like animal models, both first and second-generation antipsychotic drugs are reported to be effective in ameliorating behavioral abnormalities. It is well establish that patients with schizophrenia have been shown to display decreased sensitivity to pain, and antipsychotics are used to treat chronic pain. For example, chronic administration of phencyclidine or ketamine, psychomimetic drugs, produces decreased sensitivity to mechanical stimulation, and increased pain tolerance. The classic antipsychotic drug fluphenazine has anti-allodynic properties in multiple rodent models of nerve injury-induced neuropathic pain. An analgesic effect of quetiapine in the Cancer-induced bone pain animal model have been demonstrated. However, the mechanism of action to relive pain is still under debate and may differ between different agents. Animal models of acute and chronic pain allow evaluating the effects of analgesics drugs and other components on pain sensation and transmission, and underlining their molecular mechanism. Usually, these tests rely on an escape behavior or a withdrawal reflex as an index of pain. One known method of measuring responses to thermal stimuli involves application of a noxious thermal stimulus (hot or cold). This method has been used in order to investigate new analgesic components. Study hypothesis Schizophrenia patients and their biological relatives who have an aberrant sensation of pain also have a reduced capability to evaluate their own pain. Primary objectives
- 1.Demonstrate that schizophrenia patients who suffer from pain insensitivity also have a reduced capability to evaluate their own pain, compared to population without a mental illness.
- 2.Prove that the severity of pain insensitivity in schizophrenia patients is correlated to the degree of their ability to assess their own pain in different imaginary situations.
- 3.Demonstrate that healthy biological relatives of schizophrenia patients have aberrations in assessing their own pain.
- 4.Find the correlation between pain insensitivity in schizophrenia patients to pain insensitivity in their relatives.
- 5.Find the correlation between the degrees in pain recognition in schizophrenia patients to pain recognition in their biological relatives.
- 6.Investigate the impact of anti-psychotic drugs on pain threshold of schizophrenia patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2019
CompletedFirst Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2024
CompletedApril 26, 2022
April 1, 2022
4.3 years
March 14, 2022
April 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Schizophrenia patients and their biological relatives who have an aberrant sensation of pain also have a reduced capability to evaluate their own pain.
severity of pain insensitivity in schizophrenia patients is correlated to the degree of their ability to assess their own pain in different imaginary situations.using pain sensitivity questionnaire \& cold pressor test
20 minutes
Study Arms (1)
Cold Pressor test
EXPERIMENTALInterventions
Cold Pressor test will be done for 3 minute duration maximum
Eligibility Criteria
You may qualify if:
- Patients must meet DSM-5 criteria for a diagnosis of schizophrenia.
- Patients above 18 years of age.
- Sufficient knowledge of the Hebrew language
- A stabled mental state. If hospitalized, patients are scheduled for discharge on the basis of clinical assessment of psychiatric symptoms.
You may not qualify if:
- Mental co-morbidity.
- Peripheral neuropathies, upper limb trauma, chronic pain conditions.
- Alcohol or drug use.
- Usage of any pain reliever medications during the week before recruitment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haemek medical center
Afula, 1910500, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Einat Mader, MD
haemek medical center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 14, 2022
First Posted
April 26, 2022
Study Start
August 29, 2019
Primary Completion
December 29, 2023
Study Completion
January 15, 2024
Last Updated
April 26, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share