Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01295411
First received: February 9, 2011
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Schizophrenia
Device: Magnetic Resonance Imaging
Other: EVALUATION NEUROPSYCHOLOGICAL

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Morphological, Structural and Functional Neural Substrates of Quality of Life in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • to study the relationships between quality of life and the morphologic, structural and functional substrates in schizophrenia [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to determine whether quality of life is correlated with brain modifications using functional Magnetic Resonance Imaging [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
schizophrenia PATIENTS Device: Magnetic Resonance Imaging Other: EVALUATION NEUROPSYCHOLOGICAL

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295411

Contacts
Contact: CHRISTOPHE LANCON 0491384744 christophe.lancon@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: CHRISTOPHE LANCON       christophe.lancon@ap-hm.fr   
Principal Investigator: christophe LANCON         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01295411     History of Changes
Other Study ID Numbers: 2010-A01421-38, 2010-29
Study First Received: February 9, 2011
Last Updated: September 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2014