A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication

NCT ID: NCT00256997

Last Updated: 2013-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-04-30

Brief Summary

The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants with a history of being poorly compliant with taking their medication.

Detailed Description

This is a Phase 4, an open-label (all people know the identity of the intervention), multi-country and multi-centric (conducted in more than one center) study of risperidone long-acting formulation versus oral (having to do with the mouth) atypical antipsychotics in participants with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text revision ( DSM-IV TR) diagnosis of schizophrenia currently being treated with oral antipsychotic medication. The duration of this study will be 2 years. All the eligible participants will be randomly assigned to an oral atypical antipsychotic (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole and amisulpride) or to risperidone long-acting formulation. For risperidone long-acting formulation participants, study medication will be administered by intramuscular (into the muscle) injection every 2 weeks at doses of 25, 37.5 or 50 milligram (mg). Oral supplementation with the current oral atypical antipsychotic is required for the first 3 weeks following the initial injection and dose increase. Dose increase can be made as per product labeling. The primary measure of effectiveness is the reduction in the percentage of participants experiencing a clinical exacerbation after being in the study for 3 months. Participants' safety will be monitored throughout the study.

Conditions

Schizophrenia

Keywords

Schizophrenia; Risperidone; Risperdal Consta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Risperidone long-acting injection (LAI)

Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.

Group Type: EXPERIMENTAL

Risperidone long-acting injection (LAI)

Intervention Type: DRUG

Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.

Oral atypical Antipsychotic

Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.

Group Type: ACTIVE_COMPARATOR

Oral atypical Antipsychotic

Intervention Type: DRUG

Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.

Interventions

Risperidone long-acting injection (LAI)

Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.

Intervention Type: DRUG

Oral atypical Antipsychotic

Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: - Diagnosis of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text revision (DSM-IV TR)- Have had at least 2 hospitalizations or 2 clinical worsening of symptoms, over the past 2 years because of deteriorating adherence - Is currently receiving treatment with an antipsychotic per local product label guidelines, and has a history in the last 5 years of a satisfactory response (minimum of 6 weeks) to oral antipsychotics (excluding clozapine) - On monotherapy antipsychotic treatment as per local product label guidelines, at Baseline -Female participants must be surgically sterile, or practicing an effective method of birth control before entry and throughout the study, and have a negative urine pregnancy test at screening before study entry Exclusion Criteria: - Participants with a primary DSM-IV TR Axis I diagnosis other than schizophrenia - Female participants who are currently pregnant or breastfeeding or planning a pregnancy within 2 years of trial start - Have a serious, unstable and untreated medical illnesses, such as vascular or cardiovascular disease, history of liver or kidney disease, significant cardiac (having to do with the heart), pulmonary (having to do with the lungs), gastrointestinal, endocrine, neurological (pertaining to the nervous system) or metabolic disturbances - At significant risk of suicide or violence at study start - Evidence of substance dependence (except for nicotine and caffeine dependence) according to DSM-IV TR criteria diagnosed in the last month prior to entry

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Ortho Inc., Canada

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Inc. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Inc.

Locations

Dandenong, , Australia

Frankston, , Australia

Mount Claremont, , Australia

Newcastle, , Australia

Southport, , Australia

Calgary, Alberta, Canada

Bathurst, New Brunswick, Canada

Kentville, Nova Scotia, Canada

Sydney, Nova Scotia, Canada

Greater Sudbury, Ontario, Canada

Kingston, Ontario, Canada

Mississauga, Ontario, Canada

Beauport, Quebec, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Saint-Georges, Quebec, Canada

Battleford, Saskatchewan, Canada

Prince Albert, Saskatchewan, Canada

Montreal, , Canada

Saint John, , Canada

Co.Mayo, , Ireland

Dublin, , Ireland

Mullingar, , Ireland

Birmingham, , United Kingdom

Boston, , United Kingdom

Bristol, , United Kingdom

Burnley, , United Kingdom

Darwen, , United Kingdom

Devon, , United Kingdom

Grantham, , United Kingdom

Leicester, , United Kingdom

Lincoln, , United Kingdom

London, , United Kingdom

Morpeth, , United Kingdom

Newcastle upon Tyne, , United Kingdom

Northampton, , United Kingdom

Nottingham, , United Kingdom

Preston, , United Kingdom

Stamford, , United Kingdom

Stockton-Upon-Tees, , United Kingdom

Swansea, , United Kingdom

Teignmouth, , United Kingdom

Wallsend, , United Kingdom

Weston-super-Mare, , United Kingdom

Countries

Uruguay; Australia; Canada; Ireland; United Kingdom

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=367&filename=CR006016_CSR.pdf

Pragmatic randomized trial of Risperdal Consta versus oral atypical antipsychotics in poorly adherent subjects with schizophrenia in a routine care setting.

Other Identifiers

RISSCH4055

Identifier Type: -

Identifier Source: secondary_id

CR006016

Identifier Type: -

Identifier Source: org_study_id