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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774085
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : April 27, 2012
Information provided by:
Janssen Cilag N.V./S.A.

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

Condition or disease Intervention/treatment
Schizophrenia Other: 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.

Study Type : Observational
Actual Enrollment : 408 participants
Observational Model: Case-Only
Official Title: Electronic Schizophrenia Treatment Adherence Registry
Study Start Date : November 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Change in total length of hospitalization from retrospective to prospective period [ Time Frame: 48 months ]
    Start date, end date of full-time or partial hospitalization will be recorded both in retrospective and prospective study period.

Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Change from baseline to 24 months in Global Assessment of Functioning (GAF) scores [ Time Frame: Baseline to 24 months ]
    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"

  3. Change from baseline to 24 months in clinical deterioration [ Time Frame: Baseline, in 3-monthly intervals (± 2 weeks) for 24 months and Last visit ]
    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.

  4. Change from baseline to 24 months in assessment of remission [ Time Frame: Baseline to 24 months ]
    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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with schizophrenia

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774085

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

Responsible Party: SR MEDICAL ADVISOR, Jan-Cil Benelux Identifier: NCT00774085     History of Changes
Other Study ID Numbers: CR003886
RISSCH4002 ( Other Identifier: Janssen Cilag N.V./S.A., Belgium )
2004-002448-93 ( EudraCT Number )
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Janssen Cilag N.V./S.A.:
Risperdal Consta
Mental disorders

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents