NCT01575912

Brief Summary

Differences in pain perception between subjects with and without psychiatric illness may be influenced by the individual experience, and not primarily by the pathology, although the pathological frame may amplify it.The aim of this study is to establish if the characteristics of experimental pain feeling are influenced by the past pain experience, anxiety and emotion, independently from the diagnosis. The pain experience will be evaluated by an inventory of the potentially painful situations that one can come across through the life, to determine the following points : Number of painful events in the past, number of painful points during the last 6 months, number of painful events lasting more than 6 months, sum of pain intensities (graduated with Visual Analogic Scale VAS from 0 to 10), sum of gravity (evaluated from 0 to 5), the category of pain experience qualification (mostly affective, mostly sensorial, or both). Schizophrenic, depressed and control participants will be recruited, and their pain experience throughout life will be put it in relation to experimental pain tests results (pressure application, ischemia induction), anxiety and emotion (Hospital Anxiety and Depression scale HAD), catastrophizing (Pain Catastrophizing Scale PCS), Heart Rate (HR) variation, Blood Pressure (BP) variation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

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

Study Start

First participant enrolled

March 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

May 3, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

March 13, 2012

Results QC Date

January 31, 2017

Last Update Submit

June 9, 2017

Conditions

Keywords

SchizophreniaMajor depressionPainPast pain experience

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale Evaluation for the Pre-fixed Pressure Test

    pain tests will be realized during the first week of hospitalization for the persons hospitalized for major depression, and during the period of hospitalization (after stabilization) for the persons presenting schizophrenia. The controls are tested within one month of the study information. total range : 0 - 10. The intensity of pain increases with the value of VAS. 10 corresponds to an unbearable pain.

    one month

Study Arms (3)

schizophrenia SC

subjects with a diagnosis of schizophrenia (SC) according to the DSM-IV-TR, submitted to experimental pain tests

Other: experimental pain tests

major depression MD

subjects with a diagnosis of major depression (MD) according to the DSM-IV-TR, submitted to experimental pain tests

Other: experimental pain tests

controls C

subjects without any diagnosis of psychiatric disorder (C) submitted to experimental pain tests

Other: experimental pain tests

Interventions

controls Cmajor depression MDschizophrenia SC

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects hospitalized in the Esquirol Hospital center with schizophrenia or major depression according to the DSM-IV-TR criteria. Subjects without without known psychiatric history. Recruited persons will be matched according to age classes.

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

Related Publications (1)

  • Girard M, Plansont B, Bonnabau H, Malauzat D. Experimental pain hypersensitivity in schizophrenic patients. Clin J Pain. 2011 Nov-Dec;27(9):790-5. doi: 10.1097/AJP.0b013e31821d904c.

    PMID: 21593663BACKGROUND

MeSH Terms

Conditions

SchizophreniaDepressive Disorder, MajorPain

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 13, 2012

First Posted

April 12, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 12, 2017

Results First Posted

May 3, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations