RecruitingPhase 3interventionalRules rewrite

Phase 3: testing SEP-363856 for Generalized Anxiety Disorder

This is a global, phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, 3-arm, compared with a dummy treatment, multicenter study designed to compare the how well it works, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to dummy treatment (placebo) in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.

Official registry: https://clinicaltrials.gov/study/NCT07759128 · Otsuka Pharmaceutical Development & Commercialization, Inc. · enrollment listed as 576

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are SEP-363856, or Placebo. The registry lists allocation as randomized. This is a global, phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, 3-arm, compared with a dummy treatment, multicenter study designed to compare the how well it works, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to dummy treatment (placebo) in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.

They plan to enroll about 576 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: SEP-363856, Placebo

Primary outcome (registry wording): Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score

Who it is for (from inclusion criteria)

Ages 18 Years to any
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 (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

Who the registry excludes

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

Public study contact (from the registry)

Otsuka Call Center

844-687-8522

ProfessionalServices@otsuka-us.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

17 listed

Del Sol Research Management — Tucson, Arizona (recruiting)
Pharmacology Research Institute — Encino, California (recruiting)
California Neuroscience Research Medical Group, Inc — Sherman Oaks, California (recruiting)
Emerson Clinical Research Institute - Washington, DC — Washington D.C., District of Columbia (recruiting)
Sarkis Clinical Trials - Gainesville — Gainesville, Florida (recruiting)
Clinical Neuroscience Solutions, LLC — Jacksonville, Florida (recruiting)
Accel Research Sites - Maitland — Maitland, Florida (recruiting)
AMR Conventions Research, Inc — Warrenville, Illinois (recruiting)
Research Works, Inc — New Orleans, Louisiana (recruiting)
Adams Clinical Boston — Boston, Massachusetts (recruiting)
Vector Clinical Trials - Las Vegas — Las Vegas, Nevada (recruiting)
Adams Clinical Harlem — New York, New York (recruiting)

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FAQ about this NCT record

Is NCT07759128 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07759128?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07759128?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary