A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder

Otsuka

Status and phase: Enrolling; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: SEP-363856; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07767903

382-201-00033

2026-526034-10-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day [mg/day]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).

Enrollment: 384 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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384 participants in 2 patient groups, including a placebo group

SEP-363856

Experimental group

Description:

Participants will receive SEP-363856, 50 mg (Days 1 to 3) and 75 mg/day tablet, from Days 4 to 56, orally, QD.

Treatment:

Drug: SEP-363856

Placebo

Placebo Comparator group

Description:

Participants will receive SEP-363856-matching placebo tablet, orally, QD from Days 1 to 56.

Treatment:

Drug: Placebo