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

Condition(s) targeted: Schizophrenia

Intervention: Risperidone long-acting injection (LAI) (Drug); Oral atypical Antipsychotic (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Janssen-Ortho Inc., Canada

Official(s) and/or principal investigator(s):
Janssen Inc. Clinical Trial, Study Director, Affiliation: Janssen Inc.

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.

Official title: Pragmatic Randomized Trial of Risperdal Consta Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization

Secondary outcome:

Percentage of Participants Who Experienced a Clinical Exacerbation

Time to First Clinical Exacerbation

Time in Symptomatic (Having Symptoms) Remission

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24

Number of Participants With Clinical Global Impression of Severity (CGI-S)

Number of Participants With Clinical Global Impression of Change (CGI-C)

Number of Participants With Response to Resource Utilization Questionnaire (RUQ)

Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24

Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Dandenong, Australia

Frankston, Australia

Mt Claremont, Australia

Newcastle, Australia

Southport, Australia

Montreal, Canada

Quebec, 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

Calgary, Alberta, Canada

Bathurst, New Brunswick, Canada

Kentville, Nova Scotia, Canada

Sydney, Nova Scotia, Canada

Kingston, Ontario, Canada

Mississauga, Ontario, Canada

Sudbury, Ontario, Canada

Beauport, Quebec, Canada

Montreal, Quebec, Canada

Saint-Georges, Quebec, Canada

Battleford, Saskatchewan, Canada

Prince Albert, Saskatchewan, Canada

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

Starting date: January 2006
Last updated: November 12, 2013