Phase 4
Completed N=220
Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
Source: ClinicalTrials.gov NCT00216671 ↗Enrolled (actual)
220
Serious AEs
18.2%
Results posted
Dec 2011
Primary outcomePrimary: Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint — -38.37; -37.24 scores on a scale — p=0.784
Summary
The primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint |
-38.37; -37.24 | 0.784 |
| SECONDARY Change From Baseline in PANSS Total Score at Week 6 |
-27.48; -27.96 | — |
| SECONDARY Change From Baseline in PANSS Total Score at Week 12 |
-35.84; -34.49 | — |
| SECONDARY Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) |
-1.91; -2.03 | 0.800 |
| SECONDARY Change From Baseline to Endpoint in Global Assessment of Functioning (GAF) |
19.65; 18.72 | 0.798 |
| SECONDARY Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12 |
2.76; 1.75; 3.25; 2.96 | 0.519 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)
- acute episode of schizophrenia within 2 weeks of study entry
- o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose
- Positive And Negative Syndrome Scale (PANSS) score >=80
- Clinical Global Impression - Severity (CGI-S) score >=5
Exclusion Criteria
- DSM-IV axis I diagnosis other than schizophrenia
- known hypersensitivity or lack of response to risperidone
- pregnant or nursing females, or those without adequate contraception
- alcohol or drug abuse or dependence diagnosed in the last month prior to entry,
Data sourced from ClinicalTrials.gov (NCT00216671). 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. Informational only — not medical advice.