Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pain and Schizophrenia

This study has been terminated.
(recruitment difficulties)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01244542
First received: November 17, 2010
Last updated: August 19, 2016
Last verified: August 2016
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    acute electrical stimulation

  • Unpleasant stimuli [ Time Frame: during experimental session ] [ Designated as safety issue: No ]
    emotional pictures


Enrollment: 83
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

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 17, 2010
Last Updated: August 19, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament

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

ClinicalTrials.gov processed this record on December 07, 2016