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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07786454
- Acronym / sponsor ID
- 382-201-00034
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, GAD, Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 26 May 2029 (estimated)
- Study completion
- 2 Jun 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEP-363856 | Experimental | Drug: SEP-363856Participants will receive SEP-363856 50 mg or 75 mg tablet, orally, once daily for up to 26 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEP-363856Also: UlotarontOral tablet | Drug | SEP-363856 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation
Time frame: Throughout the trial (up to Week 27)
2 secondary outcomes
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline, Weeks 8, 14, and 26
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
Time frame: Baseline, Weeks 8, 14, and 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Otsuka Clinical Trials WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otsuka Call Center (844-687-8522, ProfessionalServices@otsuka-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (time frame: Throughout the trial (up to Week 27)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.