Phase 4
Completed N=501
Switching to Iloperidone From Other Antipsychotics in Schizophrenia
Source: ClinicalTrials.gov NCT01207414 ↗Enrolled (actual)
501
Serious AEs
3.0%
Results posted
Mar 2013
Primary outcomePrimary: Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12 — 2.826; 2.824 Score on a scale
Summary
Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult subjects with schizophrenia who require a change in their current antipsychotic treatment of risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or safety/tolerability reasons.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12 |
2.826; 2.824 | — |
| SECONDARY Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12 |
14.1; 12.7; 14.4; 16.6; 13.3; 9.9 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events or Death |
8; 7; 196; 207; 0; 0 | — |
| SECONDARY Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12 |
-0.8; -0.8; -0.9; -0.9; -0.8; -0.6 | — |
| SECONDARY Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12 |
-0.9; -0.8; -1.1; -0.9; -0.9; -0.9 | — |
| SECONDARY Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12 |
-0.9; -0.9; -0.9; -1.0; -0.8; -0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females, 18 to 64 years of age, inclusive
- DSM-IV diagnosis of schizophrenia
- Patients currently on an optimal in-label dose of one of the following permitted antipsychotic treatments for at least 30 days: risperidone, olanzapine, or aripiprazole
- Efficacy Clinical Global Impression of Severity (E-CGI-S) of 4 or 5 or
- Not tolerating one of the permitted treatments and exhibits one of the allowable side-effects
Exclusion Criteria
- Any other current Axis I disorder other than schizophrenia which is the focus of treatment;
- Acutely psychotic or patient's symptom severity requires hospitalization
- Patient with significant cardiovascular illness (myocardial infarction, cardiac arrhythmia)
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01207414). 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.