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

This study has been completed.
Sponsor:
Information provided by:
Janssen Cilag N.V./S.A.
ClinicalTrials.gov Identifier:
NCT00774085
First received: October 16, 2008
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Schizophrenia
Other: No intervention was given
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Electronic Schizophrenia Treatment Adherence Registry

Resource links provided by NLM:


Further study details as provided by Janssen Cilag N.V./S.A.:

Primary Outcome Measures:
  • Change in total length of hospitalization from retrospective to prospective period [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    Start date, end date of full-time or partial hospitalization will be recorded both in retrospective and prospective study period.


Secondary Outcome Measures:
  • Change from baseline to 24 months in Clinical Global Impression (CGI) Scale scores [ Time Frame: Baseline, (just before the first injection of long-acting injectable risperidone) to 24 months ] [ Designated as safety issue: No ]
    Patients are rated for overall severity of schizophrenia disorder using the CGI scale (7 point scale) in which 1 = Not Ill and 7 = Extremely Severe.

  • Change from baseline to 24 months in Global Assessment of Functioning (GAF) scores [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    This GAF scale rates the functioning of the patient on a scale of 1 - 100 where "1 - 10" is "Persistant danger of severely hurting self or others (eg, recurrent violence) OR persistant inability to maintain personal hygiene OR serious suicidal act with clear expectations of death" and "91- 100" is "Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his of her positive qualities. No symptoms"

  • Change from baseline to 24 months in clinical deterioration [ Time Frame: Baseline, in 3-monthly intervals (± 2 weeks) for 24 months and Last visit ] [ Designated as safety issue: No ]
    Clinical deterioration is assessed by evaluating presence or absence of deliberate self injury, suicidal or homicidal ideation, violent behaviour, and increased need in levels of care and increase in CGI by 2 points or more. The maintenance of treatment effect is documented by the time to significant deterioration of the psychotic condition. If signs of significant deterioration occurred more than once within each 3 monthly interval, this is recorded.

  • Change from baseline to 24 months in assessment of remission [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Clinical status will be assessed by presence or absence of the following core symptoms: delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing, unusual thought content, blunted affect, passive/apathetic social withdrawal, lack of spontaneity and flow of conversation. Score will be given for each symptom as follows: Score 1: Absent, Minimal, Mild; Score 2: Moderate, Moderately severe, Severe, Extreme. Symptomatic remission is defined as a clinical status where for each and every of the symptoms prespecified, a score of 1 can be given for duration of 6 months.


Enrollment: 408
Study Start Date: November 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Participants included patients treated with long-acting injectable risperidone (Risperdal Consta) in daily practice according to local label by the physicians
Other Name: No intervention was given

Detailed Description:

This is an observational (study in which patients/participants are observed) and multicentre (at multiple sites) study. This is one-country arm of a multinational study. This study consists of 2 years of retrospective (a study in which the patients are identified and then documented backward in time and 2 years of prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) study periods during which medication utilization review will be done, determining medication usage patterns and outcomes associated with the use of risperidone long acting, in clinical practice. Usage of risperidone according to label was recommended during the study. The planned recruitment period will be 6 months. Retrospective observation will be 2 years for hospitalization history and at least 1 year for medication usage. Total duration of prospective observation for each patient with a complete follow-up will be 24 months. Data collection during the follow up period will be scheduled every 3 months ± 2 weeks. In addition, this study is proposed in Belgium to satisfy the demand from Belgian Reimbursement Authorities to collect clinical data on the impact of risperidone long acting on treatment compliance, number of hospitalizations and potential prevention of relapses. Also, this data will provide documentation on switch from oral to parenteral treatment. Data will be pooled from different physicians and/or countries. The objectives of this study are: collect clinical outcome data at the request of the Belgian Reimbursement Authorities; prospectively assess medication usage patterns to document clinical efficacy and long-term treatment outcomes of risperidone long acting, in a naturalistic setting; collect retrospective data, to compare with risperidone long acting; document reasons for initiating risperidone; collect data on switch of treatment to risperidone long acting.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with schizophrenia

Criteria

Inclusion Criteria:

  • Patient who started long-acting injectable risperidone treatment after agreement between doctor and patient
  • Ambulatory patient or not chronically full-time hospitalized patient. Full-time hospitalization at the moment of inclusion for maximal 6 months
  • The treatment and treated indication according to local label
  • Patient had given informed consent in agreement with local legislation

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774085

Sponsors and Collaborators
Janssen Cilag N.V./S.A.
Investigators
Study Director: Janssen-Cilag N.V./S.A., Belgium Clinical Trial Janssen Cilag N.V./S.A.
  More Information

No publications provided

Responsible Party: SR MEDICAL ADVISOR, Jan-Cil Benelux
ClinicalTrials.gov Identifier: NCT00774085     History of Changes
Other Study ID Numbers: CR003886, RISSCH4002, 2004-002448-93
Study First Received: October 16, 2008
Last Updated: April 26, 2012
Health Authority: Belgium: Approval not required from health authorities for observational studies as per Belgian law

Keywords provided by Janssen Cilag N.V./S.A.:
Schizophrenia
Risperidone
Risperdal Consta
Propective
Retrospective
Mental disorders
Observational

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 10, 2014