A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
Pragmatic Randomized Trial of Risperdal Consta Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting
Sponsor: Janssen-Ortho Inc., Canada
Terminated
Inability to recruit number of planned patients
Listed as NCT00256997, this PHASE4 trial focuses on Schizophrenia and remains terminated or withdrawn. Sponsored by Janssen-Ortho Inc., Canada, it has been updated 8 times since 2006, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
Sep 2025 — Present [monthly]
Terminated PHASE4
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Sep 2024 — Sep 2025 [monthly]
Terminated PHASE4
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE4
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Dec 2021 — Jul 2024 [monthly]
Terminated PHASE4
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Jan 2021 — Dec 2021 [monthly]
Terminated PHASE4
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Terminated PHASE4
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Feb 2017 — Jun 2018 [monthly]
Terminated PHASE4
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Jan 2017 — Feb 2017 [monthly]
Terminated PHASE4
First recorded
Jan 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Janssen-Ortho Inc., Canada
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Bathurst, Canada , Battleford, Canada , Beauport, Canada , Birmingham, United Kingdom , Boston, United Kingdom , Bristol, United Kingdom , Burnley, United Kingdom , Calgary, Canada , Co.Mayo, Ireland , Dandenong, Australia and 33 more locations