Schizophrenia with negative symptoms
Conditions
Interventions
investigational material(s)
Generic name etc : K-163
INN of investigational material :
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigational material : Ora
Sponsors
Kowa Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with schizophrenia based on the diagnostic criteria of DSM-5. (2) Patients give their own written informed consent. etc.
Exclusion criteria
Exclusion criteria: (1) Patients with mental disorders other than schizophrenia or patients with amnestic disorders such as dementia. (2) Patients with a history of organic disorders of the brain. (3) Patients with serious gastrointestinal disorders, respiratory disorders, nervous system disorders, hematologic disorders, endocrine disorders, immune disorders or other systemic disorders. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Score of PANSS negative syndrome scale Safety: AE and ADR Efficacy: change from baseline Safety: presence or absence of incidence | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: PANSS total score etc. Safety: vital signs, laboratory tests etc. Efficacy: change from baseline etc. Safety: change from baseline etc. | — |
Countries
none
Outcome results
None listed