Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Risperidone prolonged release

Study type: Interventional

Funder types: Industry

Identifiers

NCT01726335

RISSCH4135

CR012484

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Full description

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of long-acting risperidone in participants with schizophrenia who have a previous history (in the last 12 months) of bad adherence to the oral antipsychotic treatment of first or second generation. The duration of this study will be 24 weeks and will include following visits: Screening, Baseline, Week 2, 4, 8, 12, 16, 20, 24, 38 and 50 (End visit or early withdrawal). All the eligible participants (after risperidone intolerance test during screening) will receive a dose of 25 milligram risperidone every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy and safety of the participants will primarily be evaluated by Positive and Negative Syndromes Scale and Extrapyramidal Symptom Rating Scale, respectively. Participants' safety will be monitored throughout the study.

Enrollment: 53 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
• Be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months
• Previous history of bad adhesion to oral antipsychotic treatment in the last 12 months
• Total Positive and Negative Syndrome Scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4
• Be not pregnant as showed on negative pregnancy serum test

Exclusion criteria

• Contraindication or known hypersensitivity to risperidone
• Previous history of unsatisfactory response to risperidone
• Previous history of refractivity to the other second generation antipsychotics
• Use of antipsychotic of intramuscular deposit in the last 12 months
• Other mental disturbances of DSM-IV axis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Risperidone prolonged release

Experimental group

Description:

Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.

Treatment:

Drug: Risperidone prolonged release