Phase 4
N=85
A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis
Schizophrenia · Schizoaffective Disorder · Schizophreniform Disorder · Psychotic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00246259 ↗Enrolled (actual)
85
Serious AEs
5.9%
Results posted
Nov 2013
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV) — 80.6; 79.7; -18.1; -17.7 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Risperidone long-acting injection (LAI) (Drug); Oral Antipsychotic (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Ortho Inc., Canada
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV) |
80.6; 79.7; -18.1; -17.7 | — |
| PRIMARY Time to Relapse |
80.5; 79.5 | — |
| PRIMARY Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV |
53.4; 49.5; 4.6; 9.5 | — |
| SECONDARY Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV |
3.7; 3.5; 0.1; -1.0 | — |
| SECONDARY Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV |
4.0; 4.3; -1.1; -1.5 | — |
| SECONDARY Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV |
7.2; 7.3; -0.8; -2.9 | — |
| SECONDARY Percentage of Participants With Relapse |
34.4; 16.1 | — |
| SECONDARY Number of Participants With Cognitive Assessment Using Trail A |
13; 14; 16; 9; 6; 4 | — |
| SECONDARY Number of Participants With Cognitive Assessments Using Trail B |
17; 12; 8; 5; 8; 3 | — |
| SECONDARY Total Words Score Over Time |
62.4; 59.9; 63.1; 65.4 | — |
| SECONDARY Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV |
-0.1; -0.2 | — |
| SECONDARY Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV |
0.6; 4.7 | — |
Summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations).
Eligibility Criteria
Inclusion Criteria
- In-patients or out-patients
- Primary Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder for no longer than 3 years after diagnosis and treatment of a psychotic illness
- Positive and Negative Syndrome Scale (PANSS) score of 60-120 at Visit 1 and 2
- Currently on monotherapy atypical antipsychotic treatment below local label guidelines or treatment naive
- Able to complete self-assessments in either English or French
Exclusion Criteria
- Current primary Axis-1 diagnosis other than schizophrenia, schizophreniform disorder or schizoaffective disorder, according to DSM-IV
- Current drug or alcohol dependence
- Treatment with a depot antipsychotic within 3 months of study start
- Confirmed or suspected history of lack of tolerability, hypersensitivity or allergy to risperidone
- Risperidone non-responders (based on evidence of adequate trial of treatment)
Data sourced from ClinicalTrials.gov (NCT00246259). 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.