SEP-363856 for Generalized Anxiety Disorder

Phase-Based Progress Estimates
Center for Emotional Fitness, Cherry Hill, NJGeneralized Anxiety DisorderSEP-363856 - Drug
18 - 65
All Sexes
What conditions do you have?

Study Summary

This trial will test a new drug for adults with Generalized Anxiety Disorder - open to both men & women ages 18-65. Held at 50+ global sites, up to 12 week study.

Eligible Conditions
  • Generalized Anxiety Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Week 8

Week 8
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

1%Cardiovascular insufficiency
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02969382) in the SEP-363856 ARM group. Side effects include: Headache with 9%, Somnolence with 7%, Schizophrenia with 6%, Nausea with 5%, Agitation with 5%.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

434 Total Participants · 2 Treatment Groups

Primary Treatment: SEP-363856 · Has Placebo Group · Phase 2 & 3

Experimental Group · 1 Intervention: SEP-363856 · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 8

Who is running the clinical trial?

SunovionLead Sponsor
190 Previous Clinical Trials
48,161 Total Patients Enrolled
2 Trials studying Generalized Anxiety Disorder
876 Patients Enrolled for Generalized Anxiety Disorder
CNS Medical DirectorStudy ChairSunovion
32 Previous Clinical Trials
6,728 Total Patients Enrolled
1 Trials studying Generalized Anxiety Disorder
456 Patients Enrolled for Generalized Anxiety Disorder

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with Generalized Anxiety Disorder according to the DSM-5 guidelines.

Who else is applying?

What state do they live in?
What site did they apply to?
FutureSearch Trials of Dallas, LP100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?

Frequently Asked Questions

Is this trial allowing people of advanced age to be included?

"The current enrollment criteria stipulate that only those between the ages of 18 and 65 are eligible to participate." - Anonymous Online Contributor

Unverified Answer

How many participants are there in this trial?

"Confirmed. According to, the trial which went online on March 8th 2023 is presently searching for enrollees with 434 patients desired across 13 sites." - Anonymous Online Contributor

Unverified Answer

Is it possible to still join this investigation?

"As evidenced by the data on, enrolment for this medical study is currently open; its listing was posted and last updated on March 8th of 2023." - Anonymous Online Contributor

Unverified Answer

Where are the various locations hosting this research endeavor?

"Currently, 13 medical institutions are enrolling patients in this experiment. These sites span across Torrance, Tampa and Atlanta as well as several other places. To reduce travel time and costs associated with participation, it is wise to select a clinic near you when possible." - Anonymous Online Contributor

Unverified Answer

What requirements must I meet to participate in this research project?

"This medical trial is seeking 434 individuals with a DSM-5 diagnosis of Generalized Anxiety Disorder, aged from 18 to 65. To be accepted into the study, participants must fulfil certain requirements encompassing: gender specifications; an ability to comply with procedures and appointment schedules; as well as being able to comprehend verbal and written instructions." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.