Clinical trial NCT01309373: An Epidemiological Study to Assess the Psychosocial and Symptomatic Remission and Community Integration Status in Patients With Schizophrenia
Official title: Epidemiological Study to Assess the Psychosocial and Symptomatic Remission and Community Integration Status in Patients With Schizophrenia (REINTEGRA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Remission
Psychosocial
Symtomatic
Integration
Schizoaffective
Adherence
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 1809
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen in Spanish outpatient mental health facilities, with schizophrenia or schizoaffective disorder

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag, S.A.
name: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial
role: STUDY_DIRECTOR
References: