Confirmatory Study of DSP-5423P in Patients With Schizophrenia

Sumitomo Pharma Co., Ltd.580 enrolled

Overview

The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

580

Conditions

Schizophrenia

Interventions

DSP-5423P PlaceboDRUG

DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily

DSP-5423P 40mgDRUG

DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P 80mgDRUG

DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

3 Sites

Beijing, Etc., China

53 Sites

Tokyo Etc., Japan

14 Sites

Kuala Lumpur, Etc., Malaysia

9 Sites

Manila, Etc., Philippines

Outcomes

Primary Outcomes

Change in PANSS Total Score From Baseline at Week 6

The Positive and Negative Syndrome Scale (PANSS) is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.

Time frame: Week 6

Secondary Outcomes

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

The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. The Last Observation Carried Forward (LOCF) endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P.

Time frame: Week 6 (LOCF)

Treatment Continuation Rate at 28 Weeks and 52 Weeks

Data from ClinicalTrials.gov

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