NCT05345548

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. 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. 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. 3.Demonstrate that healthy biological relatives of schizophrenia patients have aberrations in assessing their own pain.
  4. 4.Find the correlation between pain insensitivity in schizophrenia patients to pain insensitivity in their relatives.
  5. 5.Find the correlation between the degrees in pain recognition in schizophrenia patients to pain recognition in their biological relatives.
  6. 6.Investigate the impact of anti-psychotic drugs on pain threshold of schizophrenia patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

4.3 years

First QC Date

March 14, 2022

Last Update Submit

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

EXPERIMENTAL
Diagnostic Test: Cold Pressor test

Interventions

Cold Pressor testDIAGNOSTIC_TEST

Cold Pressor test will be done for 3 minute duration maximum

Cold Pressor test

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Einat Mader, MD

    haemek medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

gilat ron avraham, mph

CONTACT

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

Locations