ong-term Study of DSP-5423P in Patients with Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: JPRN-jRCT2080222713
• Lead Sponsor: Sumitomo Dainippon Pharma. Co., Ltd.

Brief Summary

ong-term application of DSP-5423P: No safety concerns were noted and the long-term effectiveness was demonstrated. Switching from DSP-5423 (tablet) administration to DSP-5423P application: No safety concerns were noted caused by the switching. No impact on the effectiveness by the switching The plasma concentration of bronanserin was higher with a higher daily dose immediately before blood sampling, and it was almost stable per daily dose immediately before blood sampling throughout the treatment period.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-07
• Study Completion: 2018-05-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 200

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 LONASEN package insert
Patients with Parkinson disease, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Adverse events (AEs) and adverse drug reaction (ADRs)<br>Extrapyramidal AEs and ADRs<br>Skin-related AEs and ADRs at the application site, etc

Secondary Outcome Measures

Name	Time	Method
efficacy<br>Change in PANSS total score from DSP-5423P baseline, etc.