Long-term safety and tolerability of SEP-363856 in adults with generalized anxiety disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, multicenter Phase 3 extension study evaluates the long-term safety and tolerability of SEP-363856 at two daily doses (50 mg or 75 mg) in adults with GAD who completed an earlier Phase 3 trial. It is an open-label design, meaning all participants receive the medication and know what they are taking. The trial focuses on safety outcomes, with additional measures related to efficacy and ongoing symptom management over a 26-week treatment period. Eligible participants are adults with GAD who previously completed a prior SEP-363856 Phase 3 study and who can adhere to the visit schedule and follow contraception requirements as applicable.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

1. Male or female participants at least 18 years of age at the time of informed consent
2. Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
3. Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
4. Participant is willing and able to comply with study procedures and visit schedule
5. i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions

Key Exclusion Criteria

1. Diagnosis other than GAD that is the primary focus of treatment
2. Clinically significant psychiatric or medical condition that may interfere with study participation
3. Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes
4. Clinically significant abnormal laboratory values or ECG findings
5. Significant suicide risk
6. Substance use/positive drug screen
7. Use of prohibited medications/therapies
8. Known sensitivity to SEP-363856

Where it's running

• Clinical Neuroscience Solutions, LLC
  Jacksonville, Florida, United States Recruiting
• Basil Clinical
  Jamaica, New York, United States Recruiting

Study contacts

• Study coordinator: Otsuka Call Center
• Email: ProfessionalServices@otsuka-us.com
• Phone: 844-687-8522

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety

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• Continuous Theta Burst Stimulation for Generalized Anxiety Disorder (cTBS for GAD)

  This study tests whether applying continuous theta burst stimulation to the right posterior parietal cortex or the right dorsolateral prefrontal cortex helps adults with generalized anxiety disorder.

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• Fixed-dose SEP-363856 vs placebo for adults with generalized anxiety disorder

  This trial tests whether a fixed 75 mg/day dose of SEP-363856 helps adults with generalized anxiety disorder more than placebo over 8 weeks.

  Recruiting at 11 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Redlands, California and 10 other locations · NCT07767903

• Fixed-dose SEP-363856 for Generalized Anxiety Disorder

  A large, global study will test whether daily doses of SEP-363856 (50 mg or 75 mg) help adults with generalized anxiety disorder more than a placebo over 8 weeks.

  Recruiting at 17 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Tucson, Arizona and 16 other locations · NCT07759128

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.