臨床研究等提出・公開システム

A Phase 2/3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in the Treatment of Adults with Generalized Anxiety Disorder

A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder

Sanada Nobuhito

Otsuka Pharmaceutical Co., Ltd.

2-16-4, Konan, Minato-ku, Tokyo, Japan

OPC_CL_SEP361-226@otsuka.jp

Drug Information Center

Otsuka Pharmaceutical Co., LTD.

2-16-4, Konan, Minato-ku, Tokyo, Japan

+81-3-6361-7314

opc_ctr@otsuka.jp

Not Recruiting

June. 19, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Male or female subject between 18 to 65 years of age.
-Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
-Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.

- Subject has DSM-5-based diagnosis of any disorder other than GAD that was the primary focus of treatment within 12 months before Screening.
-Subjects who report an inadequate response to more than 3 antidepressant treatments.
-Subject is at significant risk of harming self or others based on Investigator's judgment.
-Subject has 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.
-Female subject who is pregnant, lactating, or plans to get pregnant during the study.

Both

Generalized Anxiety Disorder

Treatment Period(8 weeks):placebo or SEP-363856 50-75 mg/day

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint (Week 8)

+81-42-648-5551

April. 10, 2023

Yes

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Supporting Materials: Study Protocol and Statistical Analysis Plan (SAP) Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data. Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

United States of America/Bulgaria/Estonia/Finland/Slovakia/Spain/Sweden