schizophrenia
Conditions
Interventions
investigational material(s)
Generic name etc : SEP-363856
INN of investigational material : -
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigational material
Sponsors
Sumitomo Dainippon Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Safety and tolerability Adverse events, clinical laboratory tests, vital signs, 12-lead ECGs | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Pharmacokinetics Plasma concentration | — |
Countries
Japan
Outcome results
None listed