A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
Information source: Janssen-Ortho Inc., Canada
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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.
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.
Clinical Details
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 ExacerbationTime 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.
Eligibility
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
Locations and Contacts
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
Additional Information
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
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