Phase 4
N=53
Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01726335 ↗Enrolled (actual)
53
Serious AEs
5.7%
Results posted
Jul 2013
Primary outcome: Primary: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2 — 55.53 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Risperidone prolonged release (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Cilag Ltd.
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2 |
55.53 | — |
| PRIMARY Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4 |
53.82 | — |
| PRIMARY Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8 |
51.28 | — |
| PRIMARY Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16 |
50.55 | — |
| PRIMARY Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24 |
48.95 | — |
| PRIMARY Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38 |
47.40 | — |
| PRIMARY Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50 |
49.72 | — |
| SECONDARY Clinical Global Impressions (CGI) - Disease Severity Score |
3.55; 3.37; 3.30; 3.21; 3.10; 2.92 | — |
| SECONDARY Extrapyramidal Symptoms Rating Scale (ESRS) Total Score |
0.460; 0.416; 0.272; 0.289; 0.271; 0.221 | — |
| SECONDARY Drug Attitude Inventory (DAI-10) |
2.78; 4.45; 4.59; 5.07 | — |
| SECONDARY Short Form-36 (SF-36) - Quality of Life |
79.2; 48.2; 73.7; 60.7; 53.8; 56.1 | — |
| SECONDARY Personal and Social Performance (PSP) Scale Score |
60.0; 66.4; 72.6; 71.7; 71.8; 69.1 | — |
| SECONDARY Global Assessment of Functioning (GAF) Scale Score |
62.6; 67.5; 72.5; 71.4; 73.9; 68.6 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01726335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.