NCT00283517

Brief Summary

The purpose of the study is to assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotic medications.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,046

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Typical duration 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

September 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

January 27, 2006

Last Update Submit

April 26, 2010

Conditions

SchizophreniaPsychotic Disorders

Keywords

Risperidone long-acting injectionAntipsychotic medicationSchizophreniaTreatment retentionObservational study

Outcome Measures

Primary Outcomes (1)

  • To assess demographic, treatment, and outcome data in schizophrenia patients receiving treatment with long-acting injectable, tablet, or liquid formulations of first generation (conventional) or second generation (atypical) antipsychotics medications.

    every 3 months over 2 years

Secondary Outcomes (1)

  • Safety assessments include the incidence, type and severity of adverse events throughout the prospective phase of the study.

    every 3 months over 2 years

Study Arms (1)

001

Drug: antipsychotics

Interventions

antipsychoticsDRUG

as prescribed

001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients starting treatment with a new antipsychotic medication, in accordance with product labeling in the local area; permitted by their physician to participate in a clinical trial

You may qualify if:

  • Patients starting treatment with a new antipsychotic medication, in accordance with product labeling in the local country
  • Permitted by their physician and by the patient to participate in a clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lambert T, Emmerson B, Hustig H, Resseler S, Jacobs A, Butcher B; e-STAR Research Group. Long acting risperidone in Australian patients with chronic schizophrenia: 24-month data from the e-STAR database. BMC Psychiatry. 2012 Mar 26;12:25. doi: 10.1186/1471-244X-12-25.

    PMID: 22448928DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing AgentsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesPsychotropic Drugs

Study Officials

  • Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

    Janssen-Cilag, S.A.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 30, 2006

Study Start

September 1, 2003

Study Completion

May 1, 2006

Last Updated

April 27, 2010

Record last verified: 2010-04