Long-term Study of DSP-5423P in Patients With Schizophrenia <Phase 3>
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sumitomo Pharma Co., Ltd.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Adverse Events and Adverse Drug Reactions, Etc.
Study Overview
Brief Summary
The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
DSP-5423P
Percutaneous
Intervention: DSP-5423P (Drug)
Outcomes
Primary Outcomes
Adverse Events and Adverse Drug Reactions, Etc.
Time Frame: week 52
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.
Secondary Outcomes
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline(Week 52, Week 52 (LOCF))