Phase 3
Completed N=593
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
Source: ClinicalTrials.gov NCT00254202 ↗Enrolled (actual)
593
Serious AEs
1.5%
Results posted
Dec 2024
Primary outcomePrimary: Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score — -12.0; -12.3; -7.1 score on a scale
◆ Published Evidence
Highly cited
205citations · ~12 / year
Applicability of a genetic signature for enhanced iloperidone efficacy in the treatment of schizophrenia.
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.
Linked Publications
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Applicability of a genetic signature for enhanced iloperidone efficacy in the treatment of schizophrenia.
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 | — |
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) and the linked publication. 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.