A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOtsuka Pharmaceutical Co., Ltd.
About this trial
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Eligibility criteria
Qualifiers
Japanese male or female participants 18 years of age or older at the time of informed consent
Diagnosed with schizophrenia according to the DSM-5®
Judged by the investigator to be clinically stable for at least 8 weeks prior to screening
PANSS total score of 80 or less and CGI-S score 4 or less at both screening and baseline
Disqualifiers
History of psychiatric hospitalization within 8 weeks prior to screening
Treatment-resistant to antipsychotic therapy (ie, within 1 year to screening, despite administration of two or more marketed antipsychotics at appropriate doses for at least 4 weeks [28 consecutive days] in accordance with the package insert, psychiatric symptoms did not improve)
History of treatment with clozapine
Unwillingness, before or during the trial period, to comply with the requirements for prior and concomitant medications/therapies as specified in the protocol or use of prohibited medications at screening or baseline as specified in the protocol.
Trial design
Treatments tested in this trial
- SEP-363856
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov