Pain and Schizophrenia | NCT01244542

Studies
Pain and Schizophrenia

NCT01244542

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Oct 5, 2017Actual

Enrollment

83Actual

Phase

Not Applicable

Conditions

Pain
Schizophrenia

Interventions

unpleasant stimuli

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment difficulties

Expanded Access Info

Start Date

Aug 2011Actual

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Nov 17, 2010

First Submission Date that Met QC Criteria

Nov 18, 2010

First Posted Date

Nov 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2017

Last Update Posted Date

Oct 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
unpleasant stimuli	Other		Healthy controls Patients with schizophrenia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Unpleasant stimuli	acute electrical stimulation	during experimental session
Unpleasant stimuli	emotional pictures	during experimental session

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Giersch, MD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques		Besançon		25030	France

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D012559	Schizophrenia
D000377	Agnosia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D019967	Schizophrenia Spectrum and Other Psychotic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided