CClinicalTrials.gg
CompletedNCT00399334Updated May 19, 2011

PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders

An observational study in Schizophrenia, Schizoaffective Disorder and Schizophreniform Disorder, sponsored by Janssen-Cilag, S.A.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-19.

Sponsored by Janssen-Cilag, S.A. · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,607
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder

Keywords

  • Schizophrenia
  • Schizoaffective
  • relapse
  • risk factors
  • Observational study
  • Antipsychotic medication
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 1,607 is above the median of 178 across 491 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Janssen-Cilag, S.A. is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,607 participants (actual)

Groups and cohorts

  • 001

    Drug: antipsychotic medications

Interventions

  • Drugantipsychotic medications

    as prescribed

06

What researchers measure

Primary outcomes

  1. Determine the epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain

    Time frame: All data is collected in just one visit (i.e. cross-sectional and retrospective data)

Secondary outcomes

  1. Describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient.

    Time frame: 1 visit (cross-sectional study)

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00399334
Lead sponsor
Janssen-Cilag, S.A.
First posted
Nov 14, 2006
Start date
Jun 2005
Completion
Dec 2005
Last update
May 19, 2011

Study contacts

Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial
study director · Janssen-Cilag, S.A.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion