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Pain and Schizophrenia

NCT ID: NCT01244542

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patients with schizophrenia

Group Type EXPERIMENTAL

unpleasant stimuli

Intervention Type OTHER

Healthy controls

controls matched with patients on age, sex and education level

Group Type ACTIVE_COMPARATOR

unpleasant stimuli

Intervention Type OTHER

Interventions

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unpleasant stimuli

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Giersch, MD

Role: STUDY_DIRECTOR

University Hospital, Strasbourg, France

Locations

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

Besançon, , France

Site Status

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

Erstein, , France

Site Status

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

Strasbourg, , France

Site Status

Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg

Strasbourg, , France

Site Status

Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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4706

Identifier Type: -

Identifier Source: org_study_id