NCT07759128 · Otsuka Pharmaceutical Development & Commercialization, Inc.
A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
What this study is about
This is a global, phase 3, randomly assigned, where neither patients nor doctors know which treatment is given, parallel-group, 3-treatment group$1, compared against an inactive treatment, conducted at multiple hospitals study designed to compare the effectiveness, 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.
View original scientific description
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.
Interventions
DRUG
SEP-363856
Oral tablet
OTHER
Placebo
Oral tablet
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Jacksonville, Florida
- New York, New York
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations