Generalized Anxiety DisorderPhase 3NCT07759128
A Trial of the Efficacy and Safety of Fixed Doses 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 17 sites in United States.
Trial summary
This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day [mg/day]) to placebo in adults at least 18 years of age with generalized anxiety… 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?
- Yes, some participants may receive a placebo
- How many people
- 576 participants
- Where
- 17 sitesUnited States
- Study dates
- 28 Jul 2026to 13 Dec 2028
- 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
- Primary diagnosis of Generalized Anxiety Disorder (GAD) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation
- Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m^2) (inclusive)
- Participant is willing and able to comply with study procedures and visit schedule
- Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests
- Willing and able to discontinue prohibited medications/therapies per protocol
- 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
- Participant is willing and able to safely discontinue all prohibited medications/therapies/herbal supplements in accordance with the protocol-required washouts prior to baseline/Day 1 and during the trial period.
Who cannot join
- Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening
- Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
- Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
- Significant suicide risk (e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale [C-SSRS] or MADRS)
- Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)
- Prior exposure to restricted treatments
Show all 9Show fewer
- Pregnant or breastfeeding females
- Participation in another investigational study within 180 days (or more than [>] 1 trial in last year)
- Known history of human immunodeficiency virus seropositivity, hepatitis B or C
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Recruiting
Adams Clinical Boston
Boston, Massachusetts, 02116
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Dougherty
- Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, 75251
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Downing
- Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Kurian
- Recruiting
Pharmacology Research Institute
Encino, California, 91316
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Grosz
- Recruiting
Sarkis Clinical Trials - Gainesville
Gainesville, Florida, 32607
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Sarkis
- Recruiting
Insight Clinical Trials
Independence, Ohio, 44131
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Stillman
- Recruiting
Clinical Neuroscience Solutions, LLC
Jacksonville, Florida, 32256
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Joyce
- Recruiting
Vector Clinical Trials - Las Vegas
Las Vegas, Nevada, 89128
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Childress
- Recruiting
Accel Research Sites - Maitland
Maitland, Florida, 32751
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Marraffino
- Recruiting
Research Works, Inc
New Orleans, Louisiana, 70125
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Doucette
- Recruiting
Adams Clinical Harlem
New York, New York, 10029
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Noone
- Recruiting
Manhattan Behavioral Medicine PLLC
New York, New York, 10036
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Joseph
- Recruiting
Sooner Clinical Research, Inc.
Oklahoma City, Oklahoma, 73116
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Sebastian
- Recruiting
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, 91403
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Shiovitz
- Recruiting
Del Sol Research Management
Tucson, Arizona, 85715
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Bupp
- Recruiting
AMR Conventions Research, Inc
Warrenville, Illinois, 60555
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Gaonkar
- Recruiting
Emerson Clinical Research Institute - Washington, DC
Washington D.C., District of Columbia, 20009
Otsuka Call Center, 844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com
Lawson
About this study
Official title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of Fixed Doses of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder
This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day [mg/day]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- SEP-363856, Placebo
- 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
PlaceboOther
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| SEP-363856 50 mg | Experimental | Participants will receive 50 milligrams (mg) SEP-363856 tablet, orally, once a day (QD) from Days 1 to 56. Receives: Drug: SEP-363856 |
| SEP-363856 75 mg | Experimental | Participants will receive 50 mg SEP-363856 tablet, orally, QD, from Days 1 to 3 and then 75 mg tablet from Days 4 to 56. Receives: Drug: SEP-363856 |
| Placebo | Placebo comparator | Participants will receive SEP-363856-matching placebo tablet, orally, QD from Days 1 to 56. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Week 8 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, Week 8
Secondary outcomes (2)
Change From Baseline at Week 8 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, Week 8
Proportion of Participants Achieving HAM-A Response Criterion at Week 8 (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline in HAM-A Total Score)
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start28 Jul 2026
- Primary completion6 Dec 2028 (estimated)
- Study completion13 Dec 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759128
- Sponsor's protocol ID
- 382-201-00032
- Other IDs
- 2026-526033-25-00
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 26 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of Fixed Doses of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT07759128
- Acronym / sponsor ID
- 382-201-00032
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, GAD, anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 6 Dec 2028 (estimated)
- Study completion
- 13 Dec 2028 (estimated)
- First posted
- 12 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, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day [mg/day]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SEP-363856 50 mg | Experimental | Drug: SEP-363856Participants will receive 50 milligrams (mg) SEP-363856 tablet, orally, once a day (QD) from Days 1 to 56. |
| SEP-363856 75 mg | Experimental | Drug: SEP-363856Participants will receive 50 mg SEP-363856 tablet, orally, QD, from Days 1 to 3 and then 75 mg tablet from Days 4 to 56. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive SEP-363856-matching placebo tablet, orally, QD from Days 1 to 56. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participants at least 18 years of age at the time of informed consent
- Primary diagnosis of Generalized Anxiety Disorder (GAD) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation
- Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m^2) (inclusive)
- Participant is willing and able to comply with study procedures and visit schedule
- Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests
Key exclusion criteria (9 listed)
- Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening
- Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
- Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
- Significant suicide risk (e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale [C-SSRS] or MADRS)
- Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)
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 50 mg, SEP-363856 75 mg |
| PlaceboOral tablet | Other | Placebo |
Primary outcome
Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline, Week 8
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.
2 secondary outcomes
Change From Baseline at Week 8 in Clinical Global Impression-Severity (CGI-S) Score
Time frame: Baseline, Week 8
Proportion of Participants Achieving HAM-A Response Criterion at Week 8 (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline in HAM-A Total Score)
Time frame: Baseline, Week 8
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 26 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.
17 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 17 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 8 inclusion and 9 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 26 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 17 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. Some participants in this study may receive a placebo. 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?
Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score (time frame: Baseline, Week 8). 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 26 Oct 2026.