What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Antioxidant, or Placebo. The registry lists allocation as randomized. 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)).
They plan to enroll about 720 people at Richmond. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
Interventions: Antioxidant, Placebo
Primary outcome (registry wording): Arm Vascular Function at Rest (Flow Mediated Dilation Test)