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

NCT01309373 | Completed

• 2 other identifiers: CR016684RISSCH4248
• Study Type: observational
• Target: 1,809
• Locations: 0 countries
• Sites: N/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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Remission; Psychosocial; Symtomatic; Integration; Schizoaffective; Adherence

Study Arms (1)

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

Interventions

Patient assessment OTHER

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.

001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Patient Outcome Assessment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

  Janssen-Cilag, S.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 7, 2011
• Study Start: November 1, 2010
• Study Completion: August 1, 2011
• Last Updated: February 14, 2012

Record last verified: 2012-02