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A Clinical Study that will measure how well SEP-363856 works and how safe it is in adults with Generalized Anxiety Disorder
EU CTIS ID: 2022-502077-42-00
What this study is testing
To evaluate the efficacy of flexible doses of SEP-363856 (50 – 75 mg/day) compared with placebo in subjects with GAD as measured by the Hamilton Anxiety Rating Scale (HAM-A) total score
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female subject between 18 to 65 years of age.
- Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder
- Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.
You likely can't join if
- Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than Generalized Anxiety Disorder, that is the primary focus of treatment
- Subjects who report an inadequate response to more than 3 antidepressant treatments
- Subject is at significant risk of harming self or others based on Investigator’s judgement.
- Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject’s ability to complete and/or participate in the study.
- Female subject who is pregnant, lactating, or plans to get pregnant during the study
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.