NCT00399334

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,607

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

November 10, 2006

Last Update Submit

May 18, 2011

Conditions

SchizophreniaSchizoaffective DisorderSchizophreniform Disorder

Keywords

SchizophreniaSchizoaffectiverelapserisk factorsObservational studyAntipsychotic medication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    1 visit (cross-sectional study)

Study Arms (1)

001

Drug: antipsychotic medications

Interventions

antipsychotic medicationsDRUG

as prescribed

001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersRecurrence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 10, 2006

First Posted

November 14, 2006

Study Start

June 1, 2005

Study Completion

December 1, 2005

Last Updated

May 19, 2011

Record last verified: 2010-04