Schizophrenia Clinical Trial
Official title:
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Verified date | April 2022 |
Source | Sumitomo Pharma Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.
Status | Completed |
Enrollment | 580 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
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 blonanserin (LONASEN) package insert - Patients with Parkinson disease - Patients who previously received blonanserin, etc. |
Country | Name | City | State |
---|---|---|---|
China | 3 Sites | Beijing, Etc. | |
Japan | 53 Sites | Tokyo Etc. | |
Korea, Republic of | 7 Sites | Seoul, Etc. | |
Malaysia | 14 Sites | Kuala Lumpur, Etc. | |
Philippines | 9 Sites | Manila, etc. | |
Russian Federation | 8 Sites | Smolensk, Etc | |
Taiwan | 6 Sites | Taipei, Etc. | |
Ukraine | 8 Sites | Poltava, Etc |
Lead Sponsor | Collaborator |
---|---|
Sumitomo Pharma Co., Ltd. |
China, Japan, Korea, Republic of, Malaysia, Philippines, Russian Federation, Taiwan, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in PANSS Total Score From Baseline at Week 6 | The Positive and Negative Syndrome Scale (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. | Week 6 | |
Secondary | Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | 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 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 Last Observation Carried Forward (LOCF) endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P. |
Week 6 (LOCF) | |
Secondary | Treatment Continuation Rate at 28 Weeks and 52 Weeks | Percentage of subjects who stay the study up to 28 weeks (196 days, all countries), and 52 weeks (364 days, in Japan) and its 95% confidence interval. | Open-Week 28 and Open-Week 52 in the open-label treatment phase |
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