Fixed-dose SEP-363856 for 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 phase 3, randomized, double-blind, parallel-group trial conducted at multiple centers. Adults 18 and older with a DSM-5-confirmed generalized anxiety disorder will be assigned to either 50 mg daily, 75 mg daily, or placebo for 8 weeks. The study aims to compare efficacy, safety, and tolerability across the three groups, using fixed daily doses of SEP-363856. Key assessments will include psychiatric evaluations and routine safety monitoring. The trial is sponsor-initiated and global in scope with several U.S. investigational sites.

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 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
3. Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2) (inclusive)
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
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. 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:

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

• Del Sol Research Management
  Tucson, Arizona, United States Recruiting
• Pharmacology Research Institute
  Encino, California, United States Recruiting
• California Neuroscience Research Medical Group, Inc
  Sherman Oaks, California, United States Recruiting
• Emerson Clinical Research Institute - Washington, DC
  Washington D.C., District of Columbia, United States Recruiting
• Sarkis Clinical Trials - Gainesville
  Gainesville, Florida, United States Recruiting
• Clinical Neuroscience Solutions, LLC
  Jacksonville, Florida, 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.

  Recruiting at 4 sites Phase 3 Intra-Cellular Therapies, Inc. · Temecula, California and 3 other locations · NCT07856420

• Testing ITI-1284 for Generalized Anxiety Disorder (GAD)

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  Recruiting at 3 sites Phase 3 Intra-Cellular Therapies, Inc. · Los Angeles, California and 2 other locations · NCT07807865

• 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.

  Recruiting at 2 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Jacksonville, Florida and 1 other locations · NCT07786454

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

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  Recruiting Ohio State University · Columbus, Ohio · NCT07774481

• 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 vs placebo for adults with generalized anxiety disorder

  This trial tests whether a fixed 75 mg/day dose of SEP-363856 helps adults with generalized anxiety disorder more than placebo over 8 weeks.

  Recruiting at 11 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Redlands, California and 10 other locations · NCT07767903

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.