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 Virtual Reality-based cognitive remediation therapy (VR-CRT), Virtual Reality-based control treatment (VR-CT), or HDACi butyrate. The registry lists allocation as randomized. The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood (depression or bipolar disorder; MD) or schizophrenia spectrum disorders.
They plan to enroll about 160 people at Frederiksberg. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Epigenetic Priming to Enhance Cognitive Training Gains and Neuroplasticity in Middle-age and Older Adults With Mood or Schizophrenia Spectrum Disorders (EPIC)
Interventions: Virtual Reality-based cognitive remediation therapy (VR-CRT), Virtual Reality-based control treatment (VR-CT), HDACi butyrate, Placebo
Primary outcome (registry wording): Cognitive composite measure