Long-term Study of DSP-5423P in Patients With Schizophrenia

Study Overview
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Brief Summary
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The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.

Official Title
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Long-term Study of DSP-5423P in Patients With Schizophrenia <Phase 3>

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: DSP-5423P


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSP-5423P<br>Percutaneous | Drug: DSP-5423P<br>* 40-80mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events and Adverse Drug Reactions, Etc. | Number of Subjects With Adverse Event (AE) and Adverse Drug Reaction (ADR) An adverse event (AE) is any untoward medical occurrence in a study subject administered a medicinal (investigational) product and which does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. An adverse drug reaction (ADR) is any AE which has a causal relationship with this treatment. | week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline | 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 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. The LOCF endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P. | Week 52, Week 52 (LOCF) |