Confirmatory Study of DSP-5423P in Patients With Schizophrenia

NCT02287584 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	Sumitomo Pharma Co., Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	580
Start date	2014-12
Completion	2018-12

Conditions

• Schizophrenia

Interventions

• DSP-5423P Placebo
• DSP-5423P 40mg
• DSP-5423P 80mg
• DSP-5423P Placebo-to-Flex
• DSP-5423P Active-to-Flex

Primary outcomes

• Change in PANSS Total Score From Baseline at Week 6 — 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.

Countries

China, Japan, Malaysia, Philippines, Russia, South Korea, Taiwan, Ukraine