NCT07759128 A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
| NCT ID | NCT07759128 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Condition | Generalized Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 576 participants |
| Start Date | 2026-07-28 |
| Primary Completion | 2028-12-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 576 participants in total. It began in 2026-07-28 with a primary completion date of 2028-12-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07759128 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Generalized Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07759128 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 576 participants.
Is NCT07759128 currently recruiting?
Yes, NCT07759128 is actively recruiting participants. Contact the research team at ProfessionalServices@otsuka-us.com for enrollment information.
Where is the NCT07759128 trial being conducted?
This trial is being conducted at Tucson, United States, Encino, United States, Sherman Oaks, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT07759128 clinical trial?
NCT07759128 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. The trial plans to enroll 576 participants.
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