Fixed-dose SEP-363856 vs placebo for adults with generalized anxiety disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a global phase 3, randomized, double-blind, placebo-controlled study comparing SEP-363856 at 75 mg per day to placebo in adults with generalized anxiety disorder. It uses a parallel-group design across multiple centers and aims to evaluate efficacy, safety, and tolerability during an 8-week treatment period. Participants must meet DSM-5 GAD criteria, be medically stable, and comply with visit schedules, with specific contraception requirements for those of reproductive potential. The trial is led by Otsuka and includes sites in California, Florida, and Massachusetts. Results will contribute to understanding whether SEP-363856 can provide meaningful symptom relief with acceptable safety in GAD.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

1. Male or female participants at least 18 years of age at the time of informed consent
2. Primary diagnosis of GAD per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation
3. Body Mass Index (BMI) 18-40 kilograms per square meter (kg/m\^2)
4. Participant is willing and able to comply with study procedures and visit schedule
5. Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests and able to comply with study procedures
6. Willing and able to discontinue prohibited medications/therapies per protocol
7. (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
8. Willing and able to discontinue prohibited medications/therapies per protocol

Key Exclusion Criteria

1. 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
2. Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
3. Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
4. Significant suicide risk e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \[C-SSRS\] or MADRS)
5. Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)
6. Prior exposure to restricted treatments
7. Pregnant or breastfeeding females
8. Participation in another investigational study within 180 days (or more than \[\>\] 1 trial in last year)
9. Known history of human immunodeficiency virus seropositivity, hepatitis B or C

Where it's running

• Anderson Clinical Research
  Redlands, California, United States Recruiting
• Clinical Neuroscience Solutions Inc. (CNS) - Orlando
  Orlando, Florida, United States Recruiting
• Adams Clinical - Watertown
  Watertown, Massachusetts, United States Recruiting
• Lumina Clinical Research Center
  Cherry Hill, New Jersey, United States Recruiting
• Basil Clinical
  Jamaica, New York, United States Recruiting
• IMA Clinical Research NYC Uptown
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Otsuka Call Center
• Email: ProfessionalServices@otsuka-us.com
• Phone: 844-687-8522

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adjunctive JNJ-99245354 for Generalized Anxiety Disorder (GAD)

  This study tests whether adding JNJ-99245354 to existing GAD treatment helps reduce anxiety more than a placebo for adults with GAD who didn’t get adequate benefit from previous treatments.

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• Long-term safety and tolerability of SEP-363856 in adults with generalized anxiety disorder

  In adults with generalized anxiety disorder, this Phase 3 open-label extension tests whether continuing SEP-363856 at 50 mg or 75 mg daily for 26 weeks is safe, tolerable, and possibly helpful.

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• Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety

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• Continuous Theta Burst Stimulation for Generalized Anxiety Disorder (cTBS for GAD)

  This study tests whether applying continuous theta burst stimulation to the right posterior parietal cortex or the right dorsolateral prefrontal cortex helps adults with generalized anxiety disorder.

  Recruiting Military Hospital 175 · Ho Chi Minh City · NCT07770919

• Fixed-dose SEP-363856 for Generalized Anxiety Disorder

  A large, global study will test whether daily doses of SEP-363856 (50 mg or 75 mg) help adults with generalized anxiety disorder more than a placebo over 8 weeks.

  Recruiting at 17 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Tucson, Arizona and 16 other locations · NCT07759128

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.