Clinical trial NCT00256997: A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Risperidone
Risperdal Consta
Lead sponsor: Janssen-Ortho Inc., Canada
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization
timeFrame: Month 3 up to Month 24
Secondary outcomes:
measure: Percentage of Participants Who Experienced a Clinical Exacerbation
timeFrame: Baseline up to Month 24
measure: Time to First Clinical Exacerbation
timeFrame: Baseline up to Month 24
measure: Time in Symptomatic (Having Symptoms) Remission
timeFrame: Baseline up to Month 24
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24
timeFrame: Baseline and Month 24
measure: Number of Participants With Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline and End of Study (Month 24 or Early Withdrawal [EW])
measure: Number of Participants With Clinical Global Impression of Change (CGI-C)
timeFrame: End of Study (Month 24 or Early Withdrawal [EW])
measure: Number of Participants With Response to Resource Utilization Questionnaire (RUQ)
timeFrame: Baseline up to Month 24
measure: Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24
timeFrame: Baseline and Month 24
measure: Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24
timeFrame: Baseline and End of Study (Month 24 or Early Termination [ET])
Other outcomes:
Locations:
city: Dandenong
country: Australia
city: Frankston
country: Australia
city: Mt Claremont
country: Australia
city: Newcastle
country: Australia
city: Southport
country: Australia
city: Calgary
country: Canada
state: Alberta
city: Bathurst
country: Canada
state: New Brunswick
city: Kentville
country: Canada
state: Nova Scotia
city: Sydney
country: Canada
state: Nova Scotia
city: Kingston
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Beauport
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Saint-Georges
country: Canada
state: Quebec
city: Battleford
country: Canada
state: Saskatchewan
city: Prince Albert
country: Canada
state: Saskatchewan
city: Montreal
country: Canada
city: Quebec
country: Canada
city: Saint John
country: Canada
city: Co.Mayo
country: Ireland
city: Dublin
country: Ireland
city: Mullingar
country: Ireland
city: Birmingham
country: United Kingdom
city: Boston
country: United Kingdom
city: Bristol
country: United Kingdom
city: Burnley
country: United Kingdom
city: Darwen
country: United Kingdom
city: Devon
country: United Kingdom
city: Grantham
country: United Kingdom
city: Leicester
country: United Kingdom
city: Lincoln
country: United Kingdom
city: London
country: United Kingdom
city: Morpeth
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Northampton
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Preston
country: United Kingdom
city: Stamford
country: United Kingdom
city: Stockton-Upon-Tees
country: United Kingdom
city: Swansea
country: United Kingdom
city: Teignmouth
country: United Kingdom
city: Wallsend
country: United Kingdom
city: Weston Super Mare
country: United Kingdom
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References: