An Observational Study to Assess Treatment & Outcomes Data in Patients Receiving Long-Acting Injectable Risperidone (e-STAR)
|ClinicalTrials.gov Identifier: NCT00774085|
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : April 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Other: No intervention was given||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||408 participants|
|Official Title:||Electronic Schizophrenia Treatment Adherence Registry|
|Study Start Date :||November 2004|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
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
- 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.
- 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.
- 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"
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774085
|Study Director:||Janssen-Cilag N.V./S.A., Belgium Clinical Trial||Janssen Cilag N.V./S.A.|