This trial is active, not recruiting.

Condition schizophrenia
Treatment dsp-5423p
Phase phase 3
Sponsor Sumitomo Dainippon Pharma Co., Ltd.
Start date December 2014
End date July 2017
Trial size 200 participants
Trial identifier NCT02335658, D4904040, JapicCTI-152765


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Adverse events and adverse drug reactions, etc.
time frame: week 52

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Long-term Study of DSP-5423P in Patients With Schizophrenia <Phase 3>
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Sumitomo Dainippon Pharma Co., Ltd..