Phase 3
Completed N=580
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT02287584 ↗Enrolled (actual)
580
Serious AEs
8.9%
Results posted
Dec 2020
Primary outcomePrimary: Change in PANSS Total Score From Baseline at Week 6 — 99.5; 101.6; 101.5; -10.8 units on a scale — p=0.007
◆ Published Evidence
Not yet cited
0citations
Association between treatment response and dose of blonanserin transdermal patch in patients with acute schizophrenia: A post hoc cluster analysis based on baseline psychiatric symptoms.
Summary
The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.
Linked Publications
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Association between treatment response and dose of blonanserin transdermal patch in patients with acute schizophrenia: A post hoc cluster analysis based on baseline psychiatric symptoms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PANSS Total Score From Baseline at Week 6 |
99.5; 101.6; 101.5; -10.8; -16.4; -21.3 | 0.007 sig |
| SECONDARY Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 |
80; 99; 107; 52; 72; 80 | — |
| SECONDARY Treatment Continuation Rate at 28 Weeks and 52 Weeks |
64.4; 62.9; 70.7; 44.4; 51.5; 50.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria
- Patients who are aged 18 years or older at informed consent
- Patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc.
Exclusion Criteria
- Patients who fall under a contraindication listed in the blonanserin (LONASEN) package insert
- Patients with Parkinson disease
- Patients who previously received blonanserin, etc.
Data sourced from ClinicalTrials.gov (NCT02287584) 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.