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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888107
• Other study ID #: CR004993
• Secondary ID: 2004-000830-35
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2013
• Last updated: June 25, 2013
• Start date: January 2005
• Est. completion date: April 2007

Study information

• Verified date: June 2013
• Source: Janssen-Cilag S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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.
• Risperidone LAI 37.5 mg
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
• Risperidone LAI 50 mg
Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag S.p.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score	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	Baseline and after 4, 12, 26, 38 and 52 weeks	No
Secondary	Clinical Global Impression-Severity (CGI-S) scale	This measure is used to evaluate disease severity at baseline (Visit 1).	Baseline	No
Secondary	Change from Baseline in Clinical Global Impression-Change (CGI-C) scale	This measure is used to evaluate disease severity at the other time points (Visits 2 to 6).	Baseline and after 4, 12, 26, 38 and 52 weeks	No
Secondary	Change from Baseline in Global Assessment of Functioning (GAF)	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.	Baseline and after 4, 12, 26, 38 and 52 weeks	No
Secondary	Change from Baseline in Drug Attitude Inventory (DAI 30)	Personal attitude towards risperidone long-acting injectable treatment is rated by a subjective questionnaire that is administered at each study visit (1 through 6).	Baseline and after 4, 12, 26, 38 and 52 weeks	No
Secondary	The number of patients who experience adverse events as a measure of safety and tolerability.		Baseline and after 4, 12, 26, 38 and 52 weeks	Yes

External Links

•   Maintenance of clinical response with risperidone long-acting injectable (R-LAI) in subjects with schizophrenia or schizoaffective disorder