Back to resultsPain and Schizophrenia
Primary Purpose
Pain, Schizophrenia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
unpleasant stimuli
Sponsored by
About this trial
This is an interventional health services research trial for Pain focused on measuring Schizophrenia, DSM IV criteria, Pain insensitivity, Painful perception, Opioid receptors
Eligibility 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
Sites / Locations
- Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques
- Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft
- Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg
- Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg
- Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with schizophrenia
Healthy controls
Arm Description
controls matched with patients on age, sex and education level
Outcomes
Primary Outcome Measures
Unpleasant stimuli
acute electrical stimulation
Unpleasant stimuli
emotional pictures
Secondary Outcome Measures
Full Information
NCT ID
NCT01244542
First Posted
November 17, 2010
Last Updated
October 4, 2017
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT01244542
Brief Title
Pain and Schizophrenia
Official Title
Pain and Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
August 2011 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Schizophrenia
Keywords
Schizophrenia, DSM IV criteria, Pain insensitivity, Painful perception, Opioid receptors
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with schizophrenia
Arm Type
Experimental
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
controls matched with patients on age, sex and education level
Intervention Type
Other
Intervention Name(s)
unpleasant stimuli
Primary Outcome Measure Information:
Title
Unpleasant stimuli
Description
acute electrical stimulation
Time Frame
during experimental session
Title
Unpleasant stimuli
Description
emotional pictures
Time Frame
during experimental session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Giersch, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Study Director
Facility Information:
Facility Name
Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft
City
Erstein Cedex
ZIP/Postal Code
67152
Country
France
Facility Name
Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg
City
Strasbourg Cedex
ZIP/Postal Code
67 091
Country
France
Facility Name
Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg
City
Strasbourg cedex
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Learn more about this trial
Pain and Schizophrenia
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