An Epidemiological Study to Assess the Psychosocial and Symptomatic Remission and Community Integration Status in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT01309373
First received: March 3, 2011
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to estimate the level of symptomatic and psychosocial remission of patients with schizophrenia and schizoaffective disorder in standard clinical practice as a function of the degree of adherence to antipsychotic treatment. The secondary objectives are to study the level of community integration of the patients included in the study, and its influencing factors, to analyze the role of various sociodemographic factors, factors related to the course of disease and the psychopathological status of the patient in community integration and remission, to analyze the potential predictors of a favorable course (symptomatic and psychosocial remission) and a poor course (no symptomatic or psychosocial remission), to assess the impact of treatment adherence on the change in the functional and community integration status of patients (based on the occupation, independence level, and degree of disability variables), to assess the significance of premorbid (academic and social) adjustment in the symptomatic and functional remission and the community integration status of patients and to correlate the level of insight to the remission and integration status of patients.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Other: Patient assessment
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Epidemiological Study to Assess the Psychosocial and Symptomatic Remission and Community Integration Status in Patients With Schizophrenia (REINTEGRA Study)

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag, S.A.:

Enrollment: 1809
Study Start Date: November 2010
Study Completion Date: August 2011
Groups/Cohorts Assigned Interventions
001
Patient assessment 2 scales will be used to assesss the remission of schizophrenia (APA scale and PSRS scale). The BPRS scale will be used to assess the clinical integration of patients.
Other: Patient assessment
2 scales will be used to assesss the remission of schizophrenia (APA scale and PSRS scale). The BPRS scale will be used to assess the clinical integration of patients.

Detailed Description:

This is a retrospective, cross-sectional, non-interventional observational, cohort epidemiological study conducted in the outpatient mental health facility setting in patients with schizophrenia. The inclusion of two patient cohorts is contemplated, recruited in mental health facilities. One cohort will involve patients estimated to have inadequate adherence to antipsychotic treatment, while the other will consist of patients with adequate adherence to such treatment. N/A

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients seen in Spanish outpatient mental health facilities, with schizophrenia or schizoaffective disorder

Criteria

Inclusion Criteria:

  • Patients with schizophrenia or schizoaffective disorder being followed-up at a mental health facility
  • Whose clinical records of recent years may be accessed
  • Who has signed informed consent, stating that he/she understands the study purpose and requirements and gives consent to participate in the study
  • In whom the psychiatrist and main caregiver may estimate the degree of adherence to antipsychotic treatment during the last two years
  • Not hospitalized in acute disorder units in the last 12 months

Exclusion Criteria:

  • Patients with psychiatric disease other than schizophrenia or schizoaffective disorder who have been diagnosed with severe to moderate mental retardation, organic disorders of personality, and/or severe and/or disabling neurological disease
  • Patients who are actively participating in any clinical trial/study
  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: NCT01309373

Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
  More Information

No publications provided

Responsible Party: Medical Director, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier: NCT01309373     History of Changes
Other Study ID Numbers: CR016684, RISSCH4248
Study First Received: March 3, 2011
Last Updated: February 13, 2012
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Janssen-Cilag, S.A.:
Schizophrenia
Schizoaffective Disorder
Remission
Psychosocial
Symtomatic
Integration
Schizoaffective
Adherence

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

ClinicalTrials.gov processed this record on July 24, 2014