NCT01244542

Brief Summary

The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable pain

Geographic Reach
1 country

5 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

November 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 5, 2017

Status Verified

September 1, 2017

Enrollment Period

3.4 years

First QC Date

November 17, 2010

Last Update Submit

October 4, 2017

Conditions

PainSchizophrenia

Keywords

SchizophreniaDSM IV criteriaPain insensitivityPainful perceptionOpioid receptors

Outcome Measures

Primary Outcomes (2)

  • Unpleasant stimuli

    acute electrical stimulation

    during experimental session

  • Unpleasant stimuli

    emotional pictures

    during experimental session

Study Arms (2)

Patients with schizophrenia

EXPERIMENTAL
Other: unpleasant stimuli

Healthy controls

ACTIVE COMPARATOR

controls matched with patients on age, sex and education level

Other: unpleasant stimuli

Interventions

unpleasant stimuliOTHER
Healthy controlsPatients with schizophrenia

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with schizophrenia (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
  • years old

You may not qualify if:

  • Past history affecting CNS
  • Intake of psychotropic drugs, except for patients
  • Metabolic disorder affecting sensory processing (diabetes)
  • Intake of benzodiazepines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques

Besançon, 25030, France

Location

Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft

Erstein, 67152, France

Location

Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67 091, France

Location

Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg

Strasbourg, 67091, France

Location

Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

PainSchizophreniaAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Anne Giersch, MD

    University Hospital, Strasbourg, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2010

First Posted

November 19, 2010

Study Start

August 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 5, 2017

Record last verified: 2017-09

Locations

FR(5)