Phase 3
N=593
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00254202 ↗Enrolled (actual)
593
Serious AEs
1.5%
Results posted
Dec 2024
Primary outcome: Primary: Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score — -12.0; -12.3; -7.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Iloperidone (Drug); Ziprasidone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score |
-12.0; -12.3; -7.1 | — |
Summary
The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.
Eligibility Criteria
Inclusion Criteria
- DSM-IV diagnosis of schizophrenia
- PANSS-T of at least 70 at screening and baseline
Exclusion Criteria
- Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
- DSM-IV diagnosis of psychiatric disorder other than schizophrenia
Data sourced from ClinicalTrials.gov (NCT00254202). 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.