An Observational Study to Assess Treatment & Outcomes Data in Patients Receiving Long-Acting Injectable Risperidone

NCT00774085 | Completed

• 3 other identifiers: CR003886RISSCH40022004-002448-93
• Study Type: observational
• Target: 408
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone.

Conditions

Schizophrenia

Keywords

Schizophrenia; Risperidone; Risperdal Consta; Propective; Retrospective; Mental disorders; Observational

Outcome Measures

Primary Outcomes (1)

• Change in total length of hospitalization from retrospective to prospective period

  Start date, end date of full-time or partial hospitalization will be recorded both in retrospective and prospective study period.

  48 months

Secondary Outcomes (4)

• Change from baseline to 24 months in Clinical Global Impression (CGI) Scale scores

  Baseline, (just before the first injection of long-acting injectable risperidone) to 24 months

• Change from baseline to 24 months in Global Assessment of Functioning (GAF) scores

  Baseline to 24 months

• Change from baseline to 24 months in clinical deterioration

  Baseline, in 3-monthly intervals (± 2 weeks) for 24 months and Last visit

• Change from baseline to 24 months in assessment of remission

  Baseline to 24 months

Study Arms (1)

Patients with Schizophrenia

Patients with Schizophrenia are treated with long-acting injectable risperidone (Risperdal Consta) in daily practice according to local label by the physicians

Other: No intervention was given

Interventions

No intervention was given OTHER

Participants included patients treated with long-acting injectable risperidone (Risperdal Consta) in daily practice according to local label by the physicians

Patients with Schizophrenia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with schizophrenia

You may qualify if:

• Patient who started long-acting injectable risperidone treatment after agreement between doctor and patient
• The treatment and treated indication according to local label
• Patient had given informed consent in agreement with local legislation

You may not qualify if:

• Patient participating in another medication related study, chronically full-time hospitalized patient, who according to the treating physician had no perspective of being discharged within the planned observation period
• Patient suffering from treatment resistant schizophrenia
• Pregnant or breastfeeding females or females with planned pregnancy within two years

Sponsors & Collaborators

• Janssen Cilag N.V./S.A.: lead

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Janssen-Cilag N.V./S.A., Belgium Clinical Trial

  Janssen Cilag N.V./S.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: November 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 27, 2012

Record last verified: 2012-04