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Sooner Clinical Research | Oklahoma City, OK

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

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Otsuka

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Generalized Anxiety Disorder

Treatments

Drug: Placebo
Drug: SEP-363856

Study type

Interventional

Funder types

Industry

Identifiers

NCT05729373
jRCT2031230152 (Registry Identifier)
SEP361-226
2022-502077-42-00 (Other Identifier)

Details and patient eligibility

About

A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.

Full description

This is a multicenter, randomized, double-blind, parallel-group, flexible dose, outpatient study evaluating the efficacy and safety of SEP-363856 flexibly dosed (50 - 75 mg/day) versus placebo over an 8-week Treatment Period in subjects with GAD. This study is projected to randomize approximately 434 subjects to 2 treatment groups (SEP-363856 [50 - 75 mg/day] or placebo) in a 1:1 ratio.

Approximately 30 additional subjects (N = 15 per treatment group) are projected to enroll in the Japan Cohort. Treatment assignment will be stratified by country. Study drug will be taken at approximately the same time each evening at bedtime .

Enrollment

434 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: (list is not all inclusive)

  • 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.

Exclusion Criteria: (list is not all inclusive)

  • Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

434 participants in 2 patient groups, including a placebo group

SEP-363856
Experimental group
Description:
dosed once daily tablet
Treatment:
Drug: SEP-363856
Placebo
Placebo Comparator group
Description:
dosed once daily tablet
Treatment:
Drug: Placebo

Trial contacts and locations

60

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Central trial contact

Otsuka Call Center

Data sourced from clinicaltrials.gov

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