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

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ClinicalTrials.gov Identifier: NCT01309373
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : February 14, 2012
Sponsor:
Information provided by:
Janssen-Cilag, S.A.

Brief Summary:
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 or disease Intervention/treatment
Schizophrenia Schizoaffective Disorder Other: Patient assessment

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

Study Type : Observational
Actual Enrollment : 1809 participants
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)
Study Start Date : November 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
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.





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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309373


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

Responsible Party: Medical Director, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier: NCT01309373     History of Changes
Other Study ID Numbers: CR016684
RISSCH4248 ( Other Identifier: Janssen-Cilag S.A., Spain )
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders