Phase 3
Completed N=508
Safety and Efficacy of MP-214 in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01625000 ↗Enrolled (actual)
508
Serious AEs
9.5%
Results posted
Apr 2021
Primary outcomePrimary: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 — -10.4; -13.8; -14.0; -20.2 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 |
-10.4; -13.8; -14.0; -20.2; -9.5 | — |
| SECONDARY Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6 |
-0.7; -0.8; -0.7; -1.2; -0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent obtained from the patient before the initiation of any study-specific procedures
- Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
- Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)
Exclusion Criteria
- Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01625000). 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.