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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subject between 18 to 65 years of age.
Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
Timeline
Screening 3 weeks
Treatment 8 weeks
Follow Up 1 weeks
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 18-65 with Generalized Anxiety Disorder who can follow the study's procedures. Participants must have a BMI of 18-40 and agree to avoid marijuana use for the duration of the study (12 weeks). Those who've had certain psychedelic therapies or ineffective antidepressant treatments are excluded.Check my eligibility
What is being tested?
The trial is testing SEP-363856, a potential new treatment for anxiety compared to a placebo. It will take place across global centers, including Japan, and participants will be involved in the study for up to approximately 12 weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with anxiety medications may include dizziness, sleepiness, nausea, dry mouth, changes in appetite or weight. Individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have been diagnosed with Generalized Anxiety Disorder.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ 8 weeks8 visits
Follow Up ~ 1 weeks0 visits
Screening ~ 3 weeks
Treatment ~ 8 weeks
Follow Up ~1 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint
Secondary outcome measures
Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint
Side effects data
From 2020 Phase 2 trial • 39 Patients • NCT0296936922%
Hallucination
19%
Fall
19%
Dizziness
16%
Confusional state
13%
Nausea
9%
Somnolence
9%
Anxiety
9%
Delusion
9%
Insomnia
9%
Hypotension
6%
Fatigue
6%
Urinary tract infection
6%
Aggression
6%
Agitation
6%
Pain
6%
Hypertension
3%
Corneal abrasion
3%
Asthenia
3%
Balance disorder
3%
Hip fracture
3%
Mental disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SEP-363856
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SEP-363856Experimental Treatment1 Intervention
dosed once daily tablet
Group II: PlaceboPlacebo Group1 Intervention
dosed once daily tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP-363856
2016
Completed Phase 2
~850
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
SunovionLead Sponsor
191 Previous Clinical Trials
50,281 Total Patients Enrolled
2 Trials studying Generalized Anxiety Disorder
876 Patients Enrolled for Generalized Anxiety Disorder
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,286 Total Patients Enrolled
2 Trials studying Generalized Anxiety Disorder
876 Patients Enrolled for Generalized Anxiety Disorder
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,348 Total Patients Enrolled
1 Trials studying Generalized Anxiety Disorder
456 Patients Enrolled for Generalized Anxiety Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never used ketamine, esketamine, arketamine, or psychedelic therapies.I haven't taken any anticonvulsants, antipsychotics, or mood stabilizers in the last year.I am between 18 and 65 years old.I have been diagnosed with or show symptoms of Generalized Anxiety Disorder.I have been diagnosed with Generalized Anxiety Disorder.I have been diagnosed with or show symptoms of Generalized Anxiety Disorder.I am between 18 and 65 years old.I have tried three or more antidepressants without enough improvement.I have not taken anticonvulsants, antipsychotics, or mood stabilizers in the last year.I am between 18 and 65 years old.I have been diagnosed with or show symptoms of Generalized Anxiety Disorder.
Research Study Groups:
This trial has the following groups:- Group 1: SEP-363856
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 8 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Weeks after you stop receiving the treatment.
Generalized Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05729373 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
How many participants are there in this trial?
"Confirmed. According to clinicaltrials.gov, the trial which went online on March 8th 2023 is presently searching for enrollees with 434 patients desired across 13 sites."
Answered by AI
Is it possible to still join this investigation?
"As evidenced by the data on clinicaltrials.gov, enrolment for this medical study is currently open; its listing was posted and last updated on March 8th of 2023."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Other
Texas
New Jersey
Pennsylvania
What site did they apply to?
Uptown Research Institute, LLC
Central Miami Medical Institute
Center for Emotional Fitness
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
2
0
Why did patients apply to this trial?
What I take right now is not working. I am hoping to reduce anxiety symptoms.
PatientReceived no prior treatments
i am a broke anxious graduate school student. To further medical research and find a better medication fdor my\\.
PatientReceived no prior treatments
I'd love to help further anything that could help us with generalized anxiety.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is this trial? How long do screening visits take? How long are the visits and how long will the trial go for? Will i be involve until the end of the study? What's the compensation?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- Center for Emotional Fitness: < 24 hours
- Boston Clinical Trials: < 48 hours
Average response time
- < 2 Days
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