Confirmatory Study of DSP-5423P in Patients With Schizophrenia

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• Schizophrenia 3,471

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 580 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Lead sponsor

Sumitomo Pharma Co., Ltd. is the lead sponsor of 25 studies on the registry; none are open to participants now.

Study arms

• Placebo comparator
  DSP-5423P Placebo

  Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.

  Drug: DSP-5423P Placebo

• Experimental
  DSP-5423P 40mg

  Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.

  Drug: DSP-5423P 40mg

• Experimental
  DSP-5423P 80mg

  Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.

  Drug: DSP-5423P 80mg

• Experimental
  DSP-5423P Placebo-to-Flex

  Percutaneous Subjects received DSP-5423P Placebo once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.

  Drug: DSP-5423P Placebo-to-Flex

• Experimental
  DSP-5423P Active-to-Flex

  Percutaneous Subjects received DSP-5423P 40mg or 80mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.

  Drug: DSP-5423P Active-to-Flex

Interventions

• DrugDSP-5423P Placebo

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

• DrugDSP-5423P 40mg

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

• DrugDSP-5423P 80mg

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

• DrugDSP-5423P Placebo-to-Flex

  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

• DrugDSP-5423P Active-to-Flex

  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

   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.

   Time frame: Week 6

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

   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.

   Time frame: Week 6 (LOCF)

2. 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.

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

Baseline characteristics

Study documents

• Study protocol · May 8, 2018
• Statistical analysis plan · Jan 10, 2018

Documents are hosted by the registry — open the source record to download them.