SEP-363856 for Anxiety
What You Need to Know Before You Apply
What is the purpose of this trial?
This Phase 3 study is testing whether two doses of an investigational drug called Ulotaront(50 mg/day and 75 mg/day) may be used as a possible treatment for adults with generalized anxiety disorder, compared with a placebo, over an 8-week period.
Will I have to stop taking my current medications?
Yes. To take part, you'll need to safely stop your current anxiety medications — such as antidepressants or anti-anxiety medications — during a screening period before starting the study, with your study doctor's guidance.
How does the drug Ulotaront differ from other treatments for anxiety?
Most approved treatments for generalized anxiety work by changing serotonin levels in the brain. Ulotaront is believed to change levels of dopamine, norepinephrine, and serotonin in the brain.
Eligibility Criteria
This trial is for adults 18 and older with generalized anxiety disorder (GAD). Participants must have a BMI between 18 and 40 and be willing to discontinue prohibited medications before starting. This is not a full list of eligibility criteria.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligilibity to participate in the trial
Treatment
Participants received Ulotaront 50 mg/day, 75 mg/day, or placebo
Follow Up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SEP-363856
Trial Overview
The trial is evaluating fixed doses of Ulotaront for efficacy, safety, and tolerability compared with placebo in adults diagnosed with generalized anxiety disorder, over an 8-week double-blind treatment period.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Group I participants take mg/day of Ulotaront from Day 1 through the end of the 8th-week Double-blind Treatment Period
Group II participants take 50 mg/day on Days 1-3, then increase to 75 mg/day through the end of the 8th-week Double-blind Treatment Period
Group III participants take matching placebo tablets on the same schedule as the active-treatment groups, throughout the 8-week Double-blind Treatment Period
Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
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