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Pain and Schizophrenia

This study has been terminated.
(recruitment difficulties)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244542
First Posted: November 19, 2010
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  Purpose
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.

Condition Intervention
Pain Schizophrenia Other: unpleasant stimuli

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pain and Schizophrenia

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Unpleasant stimuli [ Time Frame: during experimental session ]
    acute electrical stimulation

  • Unpleasant stimuli [ Time Frame: during experimental session ]
    emotional pictures


Enrollment: 83
Actual Study Start Date: August 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with schizophrenia Other: unpleasant stimuli
Active Comparator: Healthy controls
controls matched with patients on age, sex and education level
Other: unpleasant stimuli

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with schizophrenia (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
  • 18-55 years old

Exclusion Criteria:

  • Past history affecting CNS
  • Intake of psychotropic drugs, except for patients
  • Metabolic disorder affecting sensory processing (diabetes)
  • Intake of benzodiazepines
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244542


Locations
France
Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques
Besançon Cedex, France, 25030
Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft
Erstein Cedex, France, 67152
Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg
Strasbourg Cedex, France, 67 091
Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg
Strasbourg Cedex, France, 67091
Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg
Strasbourg cedex, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Anne Giersch, MD University Hospital, Strasbourg, France
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01244542     History of Changes
Other Study ID Numbers: 4706
First Submitted: November 17, 2010
First Posted: November 19, 2010
Last Update Posted: October 5, 2017
Last Verified: September 2017

Keywords provided by University Hospital, Strasbourg, France:
Schizophrenia
DSM IV criteria
Pain insensitivity
Painful perception
Opioid receptors

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders