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Completed

NCT Number: NCT02287584

Confirmatory Study of DSP-5423P in Patients With Schizophrenia

The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

3 Sites, Beijing, Etc., China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DSP-5423P Placebo

Drug

DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily

DSP-5423P 40mg

Drug

DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P 80mg

Drug

DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P Placebo-to-Flex

Drug

DSP-5423P Placebo:

DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily

DSP-5423P Flex:

DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P Active-to-Flex

Drug

DSP-5423P Active:

DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily

DSP-5423P Flex:

DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily

Primary outcomes

  1. Change in PANSS Total Score From Baseline at Week 6

    Time frame: 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.

Secondary outcomes

  1. 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

    Time frame: Week 6 (LOCF)

    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.

  2. Treatment Continuation Rate at 28 Weeks and 52 Weeks

    Time frame: Open-Week 28 and Open-Week 52 in the open-label treatment phase

    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.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 10, 2014
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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