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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335658
• Other study ID #: D4904040
• Secondary ID: JapicCTI-152765
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: May 2017

Study information

• Verified date: April 2022
• Source: Sumitomo Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• DSP-5423P
40-80mg/day

Locations

Country	Name	City	State
Japan	38 Sites	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)