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NCT Number: NCT07759128

A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in 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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Neuroscience Solutions, LLC, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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
  • 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

Treatment and study plan

SEP-363856

Drug

Oral tablet

Other names: Ulotaront

Placebo

Other

Oral tablet

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change From Baseline at Week 8 in Clinical Global Impression-Severity (CGI-S) Score

    Time frame: Baseline, Week 8

    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.

  2. 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

Other outcomes

  1. 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 9)

  2. Percentage of Participants With Any Change in Laboratory Tests Values From Baseline

    Time frame: Baseline, Weeks 4 and 8

  3. Percentage of Participants With Any Change From Baseline in Vital Signs

    Time frame: From Baseline up to Week 8

    Vital signs including blood pressure, heart rate and body temperature will be recorded.

  4. Percentage of Participants With Any Change From Baseline in Weight, Body Mass Index (BMI) and Waist Circumference

    Time frame: From Baseline up to Week 8

  5. Percentage of Participants With Any Change From Baseline in 12-Lead Electrocardiogram (ECG)

    Time frame: From Baseline up to Week 8

  6. 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)

    Time frame: Up to Week 9

    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.

  7. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Week 8

    Time frame: Baseline, Week 8

    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.

  8. Change From Baseline in Barnes Akathisia Rating Scale (BARS) at Week 8

    Time frame: Baseline, Week 8

    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).

  9. Change From Baseline in the Modified Simpson Angus Scale (MSAS) at Week 8

    Time frame: Baseline, Week 8

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Otsuka Call Center

CONTACT

[email protected]

844-687-8522

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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