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

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: DSP-5423P

Study type: Interventional

Funder types: Industry

Identifiers

NCT02335658

JapicCTI-152765 (Registry Identifier)

D4904040

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

DSP-5423P

Experimental group

Description:

Percutaneous

Treatment:

Drug: DSP-5423P