Morphological, Structural and Functional Neural Substrate... | NCT01295411

Studies
Morphological, Structural and Functional Neural Substrates of Quality of Life in Schizophrenia

NCT01295411

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Apr 28, 2015Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Magnetic Resonance Imaging
EVALUATION NEUROPSYCHOLOGICAL

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

ID	Type	Description	Link
2010-29	Other Identifier	AP HM

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2015Actual

Completion Date

Sep 2015Estimated

First Submitted Date

Feb 9, 2011

First Submission Date that Met QC Criteria

Feb 11, 2011

First Posted Date

Feb 14, 2011Estimated

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

Apr 27, 2015

Last Update Posted Date

Apr 28, 2015Estimated

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 analysis is to identify the neural correlates of quality of life scores in schizophrenia. For this, the investigators will constitute group of patients according to their quality of life scores and the investigators will analyze their differences in patterns of brain structures and activations.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
schizophrenia PATIENTS	Other		Device: Magnetic Resonance Imaging Other: EVALUATION NEUROPSYCHOLOGICAL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging	Device		schizophrenia PATIENTS
EVALUATION NEUROPSYCHOLOGICAL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to study the relationships between quality of life and the morphologic, structural and functional substrates in schizophrenia		36 months

Secondary Outcomes

Measure	Description	Time Frame
to determine whether quality of life is correlated with brain modifications using functional Magnetic Resonance Imaging		36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria (American Psychiatric Association(APA), 1994),
age over 18 years,
informed consent to participate in the studies
French as native language

Exclusion Criteria:

diagnosis other than schizophrenia on Axis I of DSM-IV,
decompensated organic disease and mental retardation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
BERNARD BELAIGUES	Assistance Publique hôpitaux de Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille		Marseille		13354	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26632639	Derived	Faget-Agius C, Boyer L, Wirsich J, Ranjeva JP, Richieri R, Soulier E, Confort-Gouny S, Auquier P, Guye M, Lancon C. Neural substrate of quality of life in patients with schizophrenia: a magnetisation transfer imaging study. Sci Rep. 2015 Dec 3;5:17650. doi: 10.1038/srep17650.

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis