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

Part of paid clinical trials in Redlands, California.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07767903
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SEP-363856 — DRUG
    Oral tablet
  • Placebo — DRUG
    Oral tablet

Study Details

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).

Key Dates

First listed
Aug 17, 2026
Start date
Aug 6, 2026
Status verified
Sep 2026
Primary completion
Oct 25, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
384 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SEP-363856
    Participants will receive SEP-363856, 50 mg (Days 1 to 3) and 75 mg/day tablet, from Days 4 to 56, orally, QD.
  • Placebo Comparator: Placebo
    Participants will receive SEP-363856-matching placebo tablet, orally, QD from Days 1 to 56.

Primary Outcome Measure

Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score [ Time Frame: Baseline, Week 8 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Anderson Clinical ResearchRedlandsCalifornia92374
Otsuka Call Center
[email protected]
844-687-8522
Anderson (PRINCIPAL_INVESTIGATOR)
Clinical Neuroscience Solutions Inc. (CNS) - OrlandoOrlandoFlorida32801
Otsuka Call Center
[email protected]
844-687-8522
Molpus (PRINCIPAL_INVESTIGATOR)
Lumina Clinical Research CenterCherry HillNew Jersey08002
Otsuka Call Center
[email protected]
844-687-8522
Corcoran (PRINCIPAL_INVESTIGATOR)
Basil ClinicalJamaicaNew York11413
Otsuka Call Center
[email protected]
844-687-8522
Rapp (PRINCIPAL_INVESTIGATOR)
Core Clinical ResearchEverettWashington98201
Otsuka Call Center
[email protected]
844-687-8522
Knutson (PRINCIPAL_INVESTIGATOR)

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