NCT01594528

Brief Summary

Numerous factors can influence the processing of pain message: the affective or emotional, the sensorial and the cognitive components. Interindividual variations at the emotional and cognitive levels may interfere with the pain message and the consecutive behavior. Some modifications in these components are observed in psychiatric troubles, but their influences on the behavior to pain have not been studied, although they have been studied in some populations characterized as non communicating, with obvious cognitive degradations (subject with dementia, older, newborns,…).In an other study in course, the past pain experience is explored in relation to results to experimental pain tests, emotional and anxious characteristics. This present pilot study aims at studying the infra-verbal behavioural signs during experimentally induced pain in subjects with schizophrenia, major depression, and controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2012

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

March 22, 2019

Completed
Last Updated

March 22, 2019

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

March 13, 2012

Results QC Date

January 31, 2017

Last Update Submit

December 17, 2018

Conditions

Keywords

schizophreniamajor depressionpainbehavior

Outcome Measures

Primary Outcomes (1)

  • Indicators / Minute

    number of corporal mobility, facial expression and sound indicators

    during pain tests (average 1 hour)

Study Arms (3)

SC

EXPERIMENTAL

behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with schizophrenia

Other: pain tests

controls

EXPERIMENTAL

behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects without any psychiatric trouble

Other: pain tests

MD

EXPERIMENTAL

behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with major depression

Other: pain tests

Interventions

pain induction with pressure application or ischemia on the arm

MDSCcontrols

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • subjects with psychiatric trouble : diagnosis of schizophrenia or major depression according to the DSM-IV-TR criteria.
  • control subjects : without known psychiatric history.
  • age between 18 and 60.

You may not qualify if:

  • absence of consent, hospitalization under constraint, absence of health insurance.
  • inability to answer the questionnaires
  • pregnancy
  • antalgic or analgesic treatment
  • allergy to latex
  • non stabilized high blood pressure, bad blood coagulation,
  • peripheral neuropathy, nerve lesion, dermatosis at the superior extremities, muscular lesion or pathology at the upper member level
  • non treated alcohol dependence
  • illegal substance consumption in the past 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Esquirol

Limoges, 87025, France

Location

MeSH Terms

Conditions

SchizophreniaDepressive Disorder, MajorPainBehavior

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDepressive DisorderMood DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Murielle Girard
Organization
Centre Hospitalier Esquirol

Study Officials

  • Dominique Malauzat, MD

    Centre Hospitalier Esquirol

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Head of Research Department

Study Record Dates

First Submitted

March 13, 2012

First Posted

May 9, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 22, 2019

Results First Posted

March 22, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations