PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders

Study PROFILe3: Clinic Observations Profile of Relapse and Readmission in Emergency/Acute Settings: Epidemiologic Survey in Schizophrenic Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00399334

Enrollment

1607

Registered

2006-11-14

Start date

2005-06-30

Completion date

2005-12-31

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder

Keywords

Schizophrenia, Schizoaffective, relapse, risk factors, Observational study, Antipsychotic medication

Brief summary

The purpose of this study is to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain.

Detailed description

Long-term treatment in schizophrenia begins in acute hospitalization. However inadequate treatment options in non-compliant patients discharged from acute inpatient settings are often leading to recidivism and frequent re-hospitalization. The objective of this epidemiologic survey is to evaluate epidemiological characteristics of relapse and readmission in acute psychiatric units. If long-term treatment in schizophrenia begins in acute hospitalization the use of the new long-acting injectable antipsychotics after an acute psychotic episode as a standard maintenance medication could prevent relapse and readmissions. This is a pharmaco-epidemiological study, which collects structured safety data and it is carried out in Spain. All data collected will be cross-sectional or retrospective and will include the following: demographic data, diagnosis, psychiatric history and co-morbidities, hospitalization record (previous 3 years), treatment record and physician's opinion on patient's treatment compliance. The primary objectives are to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain, to determine the most important risk factors which predicts the number of hospital re-admissions and to identify the impact of the clinical profile of patients with schizophrenia, and schizoaffective/schizophreniform disorders who suffer relapses. The second objective is to describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient. as prescribed

Interventions

DRUGantipsychotic medications

as prescribed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with Schizophrenia or Schizoaffective disorder with a diagnosis over 2 years and that are hospitalized in a Short-Term Psychiatric Hospitalization Unit or Acute Unit

Exclusion criteria

* Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder * Patients with Schizophrenia or Schizoaffective disorder with a diagnosis less than 2 years

Design outcomes

Primary

Measure	Time frame
Determine the epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain	All data is collected in just one visit (i.e. cross-sectional and retrospective data)

Secondary

Measure	Time frame
Describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient.	1 visit (cross-sectional study)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026