An Ascending Multiple Dose Study of SEP-363856 in Japanese Subjects with Schizophrenia
- Conditions
- schizophrenia
- Registration Number
- JPRN-jRCT2080223731
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 24
(1) Subject who has schizophrenia diagnosed by DSM-5, and in the opinion of the Investigator has been clinically stable.
(2)Subjects 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.
(3) If the subject is a minor or is hospitalized involuntarily at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
(4) Subject who has body weight is 40.0 kg or more and BMI is 18.5 or more.
(5) Negative pregnancy test
(6) Taking appropriate contraceptive measures, etc.
(1) Subject experienced an acute exacerbation of psychiatric symptoms requiring change in antipsychotic medication (with reference to drug or dose) within 3 months (90 days) before screening.
(2) Subjects who received any sustained-release formulation (depot preparation) of antipsychotic medications within 3 months (90 days) before screening.
(3) Subjects who received electroconvulsive therapy (ECT) within 3 months (90 days) before screening or is expected to require ECT during the study.
(4) Subjects has a history of alcohol or substance related disorders (according to DSM-5 criteria) within 6 months (180 days) before screening or a positive urine drug screen at screening.
(5) Subjects who received other investigational products or post-marketing clinical study drugs within 3 months (90 days) before screening or who have enrolled in but have not completed another clinical or post-marketing study before screening.
(6) Subjects with a history or complication of malignant tumor within 5 years before screening, except for adequately treated basal cell or squamous cell carcinoma of skin or cervix carcinoma in situ. Pituitary tumors of any duration are excluded.
(7) Subjects are considered by the Investigator to be affected by potent central nervous system depressants (including barbiturate).
(8) Subjects with a history or complication of hypersensitivity to any medication
(9) Subjects have previous or existing infection with HIV at screening. Subjects have a positive test for Syphilis serum reaction, Hepatitis B surface antigen or Hepatitis C antibody at screening.
(10) Subjects with specific suicidal ideation or those with a suicide attempt history
(11) Subjects have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method