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.
Summary
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 2Positive 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 ScoreExtrapyramidal 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
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
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