This is a global, phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, 2-arm, dummy treatment (placebo) controlled, multicenter trial designed to compare the how well it works, whether it is safe and how hard side effects are to live with of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to dummy treatment (placebo) over an 8-week neither you nor the study doctors know who gets the real treatment treatment period in adults with generalized anxiety disorder (GAD).
Official registry: https://clinicaltrials.gov/study/NCT07767903 · Otsuka Pharmaceutical Development & Commercialization, Inc. · enrollment listed as 384
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are SEP-363856, or Placebo. The registry lists allocation as randomized. This is a global, phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, 2-arm, dummy treatment (placebo) controlled, multicenter trial designed to compare the how well it works, whether it is safe and how hard side effects are to live with of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to dummy treatment (placebo) over an 8-week neither you nor the study doctors know who gets the real treatment treatment period in adults with generalized anxiety disorder (GAD).
They plan to enroll about 384 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of a Fixed Dose of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder
Interventions: SEP-363856, Placebo
Primary outcome (registry wording): Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score
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Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
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NCT00018057 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).
NCT04916327 · Official ClinicalTrials.gov record · Virginia Commonwealth University
Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments. this study wants to understand the brain mechanisms that produce fear and anxiety in humans.
NCT05120635 · Official ClinicalTrials.gov record · Duke University
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary