A Phase 3 interventional study of SEP-363856 in Generalized Anxiety Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment
Among 265 studies in Generalized Anxiety Disorder with a site in United States — 38 open to participants now, 53 under way, 9 of them phase 3. Generalized Anxiety Disorder · United States.
Among the 265 studies in Generalized Anxiety Disorder with a site in United States, this one has the largest planned enrollment of the 234 interventional ones that give a count, is one of 15 that started in 2026, is one of 45 in phase 3, reaches primary completion later than 45 of the 52 other live ones, and was the 261st registered.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
Browse Generalized Anxiety Disorder studies →38 of the 265 studies in Generalized Anxiety Disorder with a site in United States are open now. Recruiting first, the newest first:
Virginia Polytechnic Institute and State University · Sites in United States
Intra-Cellular Therapies, Inc. · Sites in United States
BTL Industries Ltd. · Sites in United States
Intra-Cellular Therapies, Inc. · Sites in United States
University of Miami · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 86 Generalized Anxiety Disorder studies recruiting now, 32 (37%) set no upper age limit and 52 (60%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
265 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 32 · Phase 3 51 · Phase 4 28
First in 1991; this study’s year is marked. 15 started in 2026.
This study's planned enrollment of 1,120 is above the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Median enrollment 90 across the 234 interventional studies, 220 across the 28 observational. Of the 199 that completed or were terminated, 90 (45%) have results posted.
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83 of 265 have an industry lead sponsor. The 10 most frequent:
Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 295 studies on the registry; 18 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.
Otsuka Pharmaceutical Development & Commercialization, Inc. has 6 studies filed under Generalized Anxiety Disorder — fewer than ten, so there is no comparison to draw.
20 of the studies in Generalized Anxiety Disorder with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07123467Phase 3Wayne State UniversityCannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder | 2027-08-31 |
| NCT06846320AbbVieStudy to Assess Adverse Events and Change in Disease Activity When Oral ABBV-932 is Added to Antidepressant Therapies in Adult Participants With Generalized Anxiety Disorder | 2026-11 |
| NCT06723158Boston UniversityOral Surgery Virtual Reality Glasses Study | 2026-12 |
| NCT04557891University of California, Los AngelesLow-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD) | 2026-12 |
| NCT05467683Jasper A. SmitsCO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy | 2026-12-01 |
Among the 265 studies in Generalized Anxiety Disorder with a site in United States, from their registry updates:
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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.
Key Inclusion Criteria
Key Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive SEP-363856 50 mg or 75 mg tablet, orally, once daily for up to 26 weeks.
Drug: SEP-363856
Oral tablet
Also known as: Ulotaront
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)
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.
Time frame: 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.
Time frame: Baseline, Weeks 8, 14, and 26
Percentage of Participants With Any Change in Laboratory Tests Values From Baseline
Time frame: Baseline, Weeks 8, 20, and 26
Percentage of Participants With Any Change in Potentially Clinically Relevant Vital Signs From Baseline
Vital signs including blood pressure, heart rate and body temperature will be recorded.
Time frame: From Baseline up to Week 26
Percentage of Participants With Any Change From Baseline in Weight, Body Mass Index (BMI) and Waist Circumference
Time frame: Baseline, Weeks 8 and 26
Percentage of Participants With Any Change From Baseline in 12-Lead Electrocardiogram (ECG)
Time frame: From Baseline up to Week 26
Number of Participants With Changes in Frequency and Severity of Suicidal Ideation and Suicidal Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician administered, interview-based rating scale which systematically assesses suicidal ideation, suicidal behavior and non-suicidal self-injurious behavior. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, suicidal behavior, completed suicide), suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan and intent) and non-suicidal self-injurious behavior.
Time frame: Up to Week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
The AIMS total score commonly uses the sum of items 1-7 and ranges from 0 to 28 (0 = no abnormal movements; 28 = maximum severity on rated items); higher scores indicate more severe abnormal involuntary movements (worse outcome). A higher total score indicates more frequent or severe involuntary movements across multiple muscle groups.
Time frame: Baseline, Weeks 8, 14, and 26
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
The BARS is a rating scale intended for the assessment of neuroleptic-induced akathisia. The global score ranges from 0 to 5 (0 = no akathisia; 5 = severe akathisia), and higher scores indicate more severe akathisia (worse outcome).
Time frame: Baseline, Weeks 8, 14, and 26
Change From Baseline in the Modified Simpson Angus Scale (MSAS)
The MSAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item will be rated on a 5-point scale, with a score of zero representing absence of symptoms, and a score of 4 representing a severe condition. The MSAS Total Score is the sum of the scores for all 10 items, ranging from 0 to 40. Higher scores indicate more severe movement disorder.
Time frame: Baseline, Weeks 8, 14, and 26
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
Data sharing details ↗ · clinical-trials.otsuka.com
Started Oct 2026 (actual). Primary completion is estimated for May 2029, 31 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: SEP-363856
Generalized Anxiety Disorder →
Otsuka Pharmaceutical Development & Commercialization, Inc. →