NCT01295411

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

February 9, 2011

Last Update Submit

April 27, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • to study the relationships between quality of life and the morphologic, structural and functional substrates in schizophrenia

    36 months

Secondary Outcomes (1)

  • to determine whether quality of life is correlated with brain modifications using functional Magnetic Resonance Imaging

    36 months

Study Arms (1)

schizophrenia PATIENTS

OTHER
Device: Magnetic Resonance ImagingOther: EVALUATION NEUROPSYCHOLOGICAL

Interventions

schizophrenia PATIENTS
schizophrenia PATIENTS

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Schizophrenia

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • BERNARD BELAIGUES

    Assistance Publique hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 14, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2015

Study Completion

September 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations