Generalized Anxiety DisorderPhase 3NCT07786454
A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder
A Phase 3 study testing SEP-363856 in people with Generalized Anxiety Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites in United States.
Trial summary
This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- SEP-363856
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2026to 2 Jun 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants at least 18 years of age at the time of informed consent
- 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 cannot join
- 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 efficacy outcomes
- Clinically significant abnormal laboratory values or ECG findings
- Significant suicide risk
- Substance use/positive drug screen
- Use of prohibited medications/therapies
- Known sensitivity to SEP-363856
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Clinical Neuroscience Solutions, LLC
Jacksonville, Florida, 32256
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Joyce
- Recruiting
Basil Clinical
Jamaica, New York, 11413
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Rapp
About this study
Official title: 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
This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- SEP-363856
- Keywords
- Generalized Anxiety Disorder, GAD, Anxiety
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEP-363856Drug
Also called Ulotaront
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| SEP-363856 | Experimental | Participants will receive SEP-363856 50 mg or 75 mg tablet, orally, once daily for up to 26 weeks. Receives: Drug: SEP-363856 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation
Measured: Throughout the trial (up to Week 27)
Secondary outcomes (2)
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
The HAM-A is a clinician-administered rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is scored on a 5-point Likert-type scale ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating greater severity.
Measured: Baseline, Weeks 8, 14, and 26
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
The CGI-S is a clinician-rated assessment of the participant's current illness state on a 7-point Likert-type scale (1=normal, not at all ill; 7=among the most extremely ill participants), where a higher score is associated with greater illness severity. A decrease in value indicates improvement.
Measured: Baseline, Weeks 8, 14, and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start8 Oct 2026
- Primary completion26 May 2029 (estimated)
- Study completion2 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786454
- Sponsor's protocol ID
- 382-201-00034
- Other IDs
- 2026-526032-40-00, 1014199
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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. Small studies with less than 25 participants are excluded from data sharing.