RecruitingPhase 3interventionalRules rewrite

Phase 3: testing SEP-363856 for Generalized Anxiety Disorder

This is a global, Phase 3, multicenter, open-label extension trial designed to measure the long-term safety, tolerability and how well it works of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.

Official registry: https://clinicaltrials.gov/study/NCT07786454 · Otsuka Pharmaceutical Development & Commercialization, Inc. · enrollment listed as 1,120

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are SEP-363856. The registry lists allocation as na. This is a global, Phase 3, multicenter, open-label extension trial designed to measure the long-term safety, tolerability and how well it works of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.

They plan to enroll about 1,120 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Multicenter, Open-Label Extension Trial to Evaluate the Safety and Tolerability of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder

Interventions: SEP-363856

Primary outcome (registry wording): Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation

Who it is for (from inclusion criteria)

Ages 18 Years to any
Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
Participant is willing and able to comply with study procedures and visit schedule
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

Who the registry excludes

Diagnosis other than GAD that is the primary focus of treatment
Clinically significant psychiatric or medical condition that may interfere with study participation
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 how well it works outcomes
Clinically significant abnormal laboratory values or ECG findings
Significant suicide risk
Substance use/positive drug screen
Use of prohibited medications/therapies

Public study contact (from the registry)

Otsuka Call Center

844-687-8522

ProfessionalServices@otsuka-us.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

Clinical Neuroscience Solutions, LLC — Jacksonville, Florida (recruiting)
Basil Clinical — Jamaica, New York (recruiting)

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FAQ about this NCT record

Is NCT07786454 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07786454?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07786454?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary