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Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder

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ClinicalTrials.gov Identifier: NCT01888107
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag S.p.A.

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE January 2005
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]
Maintenance= Symptom severity assessed with PANSS scale vs baseline (Total, positive, negative, general psychopathology and cognitive cluster score); Remission= percentage of patients with 8 specific items PANSS simultaneously scoring <= 3 for at least 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: Baseline ]
    This measure is used to evaluate disease severity at baseline (Visit 1).
  • Change from Baseline in Clinical Global Impression-Change (CGI-C) scale [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]
    This measure is used to evaluate disease severity at the other time points (Visits 2 to 6).
  • Change from Baseline in Global Assessment of Functioning (GAF) [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]
    GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. Lower scores indicate worsening.
  • Change from Baseline in Drug Attitude Inventory (DAI 30) [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]
    Personal attitude towards risperidone long-acting injectable treatment is rated by a subjective questionnaire that is administered at each study visit (1 through 6).
  • The number of patients who experience adverse events as a measure of safety and tolerability. [ Time Frame: Baseline and after 4, 12, 26, 38 and 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
Official Title  ICMJE Maintenance of Clinical Response With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
Brief Summary The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy. The secondary aim is to investigate prospectively (a study that starts with the present condition of a population of individuals and follows them into the future) the prevalence of patients who met standardized remission criteria (according to Andreasen et al. criteria) and the psychopathological, psychosocial and subjective predictors of achieving remission.
Detailed Description This is a prospective, open-label, (all people know the identity of the intervention), single-arm study conducted at 47 sites in Italy between January 2005 and April 2007. Approximately 338 patients with schizophrenia or schizoaffective disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy will be switched directly to RLAI without an oral risperidone run-in (the elapsed time before a trial is started when no treatment is given to patients in the study). They will be considered either not optimally treated or symptom-free. Patients will be either not hospitalized or living in residential structures at the time of the enrollment as well as throughout the study. The maximum duration of study participation will be 52 weeks. Patient safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE
  • Drug: Risperidone Long-acting Injectable (LAI) 25 mg
    Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
  • Drug: Risperidone LAI 37.5 mg
    Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
  • Drug: Risperidone LAI 50 mg
    Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
Study Arms  ICMJE Experimental: Risperidone Long-acting Injectable (LAI)
Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.
Interventions:
  • Drug: Risperidone Long-acting Injectable (LAI) 25 mg
  • Drug: Risperidone LAI 37.5 mg
  • Drug: Risperidone LAI 50 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2013)
347
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
  • Required long-term antipsychotic therapy at the time of recruitment
  • Symptomatically stable and taking the same dose of antipsychotic agents for at least one month before the baseline visit (considered stable if there have been no appreciable change in symptoms over the previous month, regardless of the severity of their symptoms)
  • Patients or their legal representatives provided their written informed consent prior to enrollment in the study

Exclusion Criteria:

  • Patients who had received clozapine during the previous 3 months
  • Participated in an investigational drug trial in the previous 30 days
  • Previously been shown to be either intolerant or non-responsive to risperidone therapy
  • Presence of a serious unstable medical condition, such as a history or current symptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome
  • Pregnant or breast-feeding; female patients of childbearing potential not using adequate contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888107
Other Study ID Numbers  ICMJE CR004993
2004-000830-35 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen-Cilag S.p.A.
Study Sponsor  ICMJE Janssen-Cilag S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial Janssen-Cilag S.p.A.
PRS Account Janssen-Cilag S.p.A.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP