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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Risperidone Long-acting Injectable (LAI) 25 mg

Risperidone LAI 37.5 mg

Risperidone LAI 50 mg

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Antipsychotics, Risperidone, Long-acting injectable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Risperidone Long-acting Injectable (LAI)

Arm Description

Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical Global Impression-Severity (CGI-S) scale

This measure is used to evaluate disease severity at baseline (Visit 1).

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).

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.

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).

The number of patients who experience adverse events as a measure of safety and tolerability.

Full Information

NCT ID

NCT01888107

First Posted

June 25, 2013

Last Updated

June 25, 2013

Sponsor

Janssen-Cilag S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT01888107

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen-Cilag S.p.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder

Keywords

Schizophrenia, Schizoaffective Disorder, Antipsychotics, Risperidone, Long-acting injectable

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

347 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Risperidone Long-acting Injectable (LAI)

Arm Type

Experimental

Arm Description

Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.

Intervention Type

Drug

Intervention Name(s)

Risperidone Long-acting Injectable (LAI) 25 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Risperidone LAI 37.5 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Risperidone LAI 50 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score

Description

Time Frame

Baseline and after 4, 12, 26, 38 and 52 weeks

Secondary Outcome Measure Information:

Title

Clinical Global Impression-Severity (CGI-S) scale

Description

This measure is used to evaluate disease severity at baseline (Visit 1).

Time Frame

Baseline

Title

Change from Baseline in Clinical Global Impression-Change (CGI-C) scale

Description

This measure is used to evaluate disease severity at the other time points (Visits 2 to 6).

Time Frame

Baseline and after 4, 12, 26, 38 and 52 weeks

Title

Change from Baseline in Global Assessment of Functioning (GAF)

Description

Time Frame

Baseline and after 4, 12, 26, 38 and 52 weeks

Title

Change from Baseline in Drug Attitude Inventory (DAI 30)

Description

Personal attitude towards risperidone long-acting injectable treatment is rated by a subjective questionnaire that is administered at each study visit (1 through 6).

Time Frame

Baseline and after 4, 12, 26, 38 and 52 weeks

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen-Cilag S.p.A., Italy Clinical Trial

Organizational Affiliation

Janssen-Cilag S.p.A.

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1372&filename=CR004993_CSR.pdf

Description

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

Learn more about this trial

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

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