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

Information source: Janssen-Cilag Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Risperidone prolonged release (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen-Cilag Ltd.

Official(s) and/or principal investigator(s):
Janssen-Cilag Ltd. Clinical trial, Study Director, Affiliation: Janssen-Cilag Ltd.


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).

Clinical Details

Official title: An Open-Label Study of Oral Antipsychotics Replacement by Prolonged Release Risperidone (Risperdal Consta) in Schizophrenic Subjects With Bad Adhesion to the Treatment

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50

Secondary outcome:

Clinical Global Impressions (CGI) - Disease Severity Score

Extrapyramidal Symptoms Rating Scale (ESRS) Total Score

Drug Attitude Inventory (DAI-10)

Short Form-36 (SF-36) - Quality of Life

Personal and Social Performance (PSP) Scale Score

Global Assessment of Functioning (GAF) Scale Score

Detailed 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.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Curitiba, Brazil

Porto Alegre, Brazil

Rio De Janeiro, Brazil

Salvador, Brazil

Sao Paulo, Brazil

Additional Information

Starting date: January 2006
Last updated: April 10, 2014

Page last updated: August 23, 2015

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