Clinical Trials List
2014-10-09 - 2018-12-31
Phase III
Terminated6
ICD-10F20.9
Schizophrenia, unspecified
Confirmatory Study of DSP-5423P in Patients with Schizophrenia
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Trial Applicant
COVANCE TAIWAN SERVICES LIMITED
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Sponsor
Sumitomo Dainippon Pharma. Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- YI-TING LIN Division of Psychiatry
- YI-LING CHIEN Division of Psychiatry
- Chen-Chung Liu Division of Psychiatry
- CHIH-MIN LIU Division of Psychiatry
- 謝明憲 Division of Psychiatry
The Actual Total Number of Participants Enrolled
3 Stop recruiting
Co-Principal Investigator
- Cheng-Ta Li 無
- W. C. LIN 無
- Mu-Hong Chen 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary endpoint is the change in PANSS total score from baseline at Week 6.
Secondary Endpoints
-Change in PANSS subscale scores from baseline at Week 6
-Change in PANSS five-factor modelNote scores from baseline at Week 6
-Change in Clinical Global Impressions– Severity of Illness (CGI-S) score from baseline at Week 6
-Change in PANSS total score from the last evaluation before the initial application of DSP-5423P at each visit
-Change in PANSS subscales from the last evaluation before the initial application of DSP-5423P at each visit
-Change in PANSS five-factor models from the last evaluation before the initial application of DSP-5423P at each visit
-Proportion of subjects who achieve a response, defined as 20% or greater improvement from baseline in PANSS total score at Week 6
-Change in CGI-S score from the last evaluation before the initial application of DSP-5423P at each visit
-Time to treatment discontinuation from the initial application in the open-label treatment phase
Inclution Criteria
＜The procedure in Japan is described in the Japan Appendix.>
Patients who meet all the following criteria at screening will be included in the study:
1.Patients who have schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), diagnostic criteria
2.Patients who have psychiatric symptoms (eg, aggravated delusions) with schizophrenia showing exacerbation within 2 months (60 days) before screening
3.Patients with a PANSS score of 4 (moderate) or higher for 2 or more of the following 5 items: delusions (P1), conceptual disorganization (P2), hallucinations (P3), suspiciousness (P6), and unusual thought content (G9)
4.Patients with a total PANSS score of 80 or higher
5.Patients who can be hospitalized from screening until the scheduled date of Visit 4
6.Patients who are aged 18 years or older at informed consent
7.Patients who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who voluntarily provide written consent to participate in the study. If the patient is a minor at informed consent, written consent will be obtained from a legally acceptable representative
Note in addition to that obtained from the patient.
Note: A legally acceptable representative is defined as a person within the second degree of kinship, in principle, who can act in the patient’s best interest in the context of daily lifestyle and the existing mental relationship between the two parties.
8.Female patients, who are premenopausal and of childbearing potential, with negative pregnancy test (urine) results at screening
9.Patients who agree to practice appropriate contraception, when the patients or their partners are of childbearing potential
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from the study.
1.Patients in a coma
2.Patients under the strong influence of central nervous system depressants such as barbituric acid derivatives
3.Patients receiving treatment with adrenaline, azole antifungals (excluding drugs for external use), or human immunodeficiency virus (HIV) protease inhibitors
4.Patients with a history of or current neuroleptic malignant syndrome, tardive dyskinesia, or water intoxication
5.Patients with Parkinson’s disease
6.Patients with active suicidal ideation or those with a suicide attempt history who are considered ineligible for the study by the Investigator
7.Patients with HbA1c (NGSP) of 8.4% or higher
8.Patients with physical exhaustion accompanied by conditions such as dehydration and malnutrition
The Estimated Number of Participants
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Taiwan
102 participants
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Global
500 participants
