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New treatment option for Schizophrenia
Official title A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT07225712
What this study is testing
What is SEP-363856?
SEP-363856 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- No changes in antipsychotic medication for at least 6 weeks before screening (excluding minor dose adjustments for side effects)
You likely can't join if
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.