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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07759128
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 — OTHER
    Oral tablet

Study Details

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.

Key Dates

First listed
Aug 12, 2026
Start date
Jul 28, 2026
Status verified
Aug 2026
Primary completion
Dec 6, 2028
Completion
Dec 13, 2028

Study Design

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

Arms

  • Experimental: SEP-363856 50 mg
    Participants will receive 50 milligrams (mg) SEP-363856 tablet, orally, once a day (QD) from Days 1 to 56.
  • Experimental: SEP-363856 75 mg
    Participants will receive 50 mg SEP-363856 tablet, orally, QD, from Days 1 to 3 and then 75 mg tablet from Days 4 to 56.
  • 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 (3)

FacilityCityStateZIPSite coordinators
Clinical Neuroscience Solutions, LLCJacksonvilleFlorida32256
Otsuka Call Center
[email protected]
844-687-8522
Joyce (PRINCIPAL_INVESTIGATOR)
Manhattan Behavioral Medicine PLLCNew YorkNew York10036
Otsuka Call Center
[email protected]
844-687-8522
Joseph (PRINCIPAL_INVESTIGATOR)
FutureSearch Trials of DallasDallasTexas75251
Otsuka Call Center
[email protected]
844-687-8522
Downing (PRINCIPAL_INVESTIGATOR)

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Clinical Neuroscience Solutions, LLC· Jacksonville, FLManhattan Behavioral Medicine PLLC· New York, NYFutureSearch Trials of Dallas· Dallas, TX

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