Confirmatory Study of DSP-5423P in Patients with Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: JPRN-jRCT2080222637
• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.

Brief Summary

The superiority of both DSP-5423P 40 mg and 80 mg to placebo was demonstrated in terms of change in PANSS total score at Week 6, analyzed as the primary endpoint. The long-term efficacy of DSP-5423P treatment was demonstrated. No safety concerns were noted in long-term DSP-5423P treatment. In the Japanese subpopulation, the efficacy of DSP-5423P showed similar trends to those seen in the overall pop, and there were no trends for marked differences in the safety profile compared with the overall pop.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-23
• Study Completion: 2018-12-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 580

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
- Patients who previously received blonanserin, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>The primary endpoint is the change in PANSS total score from baseline at Week 6.

Secondary Outcome Measures

Name	Time	Method
efficacy<br>- Change in PANSS subscale scores from baseline at Week 6<br>- Change in PANSS five-factor modelNote scores from baseline at Week 6<br>- Change in Clinical Global Impressions - Severity of Illness (CGI-S) score from baseline at Week 6<br>- Change in PANSS total score from the last evaluation before the initial application of DSP-5423P at each visit<br>- Change in PANSS subscales from the last evaluation before the initial application of DSP-5423P at each visit<br>- Change in PANSS five-factor models from the last evaluation before the initial application of DSP-5423P at each visit<br>- Proportion of subjects who achieve a response, defined as 20% or greater improvement from baseline in PANSS total score at Week 6