Epigenetic Enhancement of Cognitive Training in Aging Mood and Schizophrenia Spectrum Disorder Populations
Key facts
- Where
- Frederiksberg, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 35 and 75 years old?
Source: NCT07404085, who can take part
Where in Denmark
- Neurocognition and Emotion Across Disorders (NEAD Brain Centre, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Frederiksberg HospitalFrederiksberg, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Trial code
- NCT07404085
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
Epigenetic Priming to Enhance Cognitive Training Gains and Neuroplasticity in Middle-age and Older Adults With Mood or Schizophrenia Spectrum Disorders (EPIC)
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.
The investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs. a VR-based control treatment combined with placebo will improve global cognition (primary outcome measure) over three weeks.
Secondly, the investigators hypothesize that VR-CRT with placebo will improve cognition relative to the VR control treatment with placebo, although to a lesser extent than VR-CRT with HDACi butyrate.
Thirdly, the investigators hypothesize that the HDACi butyrate with VR control treatment will not produce cognitive improvements relative to placebo with VR control treatment.
Finally, the investigators hypothesize that the combined treatment (VR-CRT + HDACi butyrate) will enhance neuroplasticity (exploratory outcome) vs. VR control with placebo, as indicated by increase in hippocampal volume and/or memory-related activity shown with structural and functional MRI.
Inclusion: Confirmed ICD-10 diagnosis of BD or recurrent UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14) or SSD assessed relatively stable by primary clinician at time of inclusion; Subjective cognitive complaints (self-reported: COBRA ≥12) or objectively-verified cognitive impairment (measured using Screening for Cognitive Impairment in Psychiatry SCIP: total score or at least two subscores ≥ 0.5 SD below expected norms); Fluency in Danish language.
Exclusion: Previous severe head trauma; Received electroconvulsive therapy < 2 months prior to participation; Neurological disorders (including dementia); Severe Physical illness; Kidney disease; Cardiovascular disease; Diabetes; History of epilepsy; Hypertension (>140 systolic or > 90 diastolic mm Hg); Serum lithium levels > 0.8 mmol/L; Dyslexia; Alcohol or substance abuse; Pregnancy or breastfeeding; BMI >35; Bodyweight < 45kg; Daily use of benzodiazepines > 22.5 mg. oxazepam or > 7.5 mg. diazepam per day.