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Epigenetic Enhancement of Cognitive Training in Aging Mood and Schizophrenia Spectrum Disorder Populations

RecruitingNAAges 35 Years - 75 YearsAllMental Health Centre Copenhagen, Bispebjerg and F…
NCT07404085 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Neurological disorders (including dementia) * Dyslexia * Severe Physical illness * Kidney disease * Cardiovascular disease * Diabetes * Alcohol or substance abuse * Previous severe head trauma * History of epilepsy * Pregnancy or breastfeeding * BMI \>35 * Bodyweight \< 45kg * Daily use of benzodiazepines \> 22.5 mg. oxazepam or \> 7.5 mg. diazepam per day * Serum lithium levels \> 0.8 mmol/L * Received electroconvulsive therapy \< 2 months prior to participation * Hypertension (\>140 systolic or \> 90 diastolic mm Hg)
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What it tests

  • Virtual Reality-based cognitive remediation therapy (VR-CRT)
  • Virtual Reality-based control treatment (VR-CT)
  • HDACi butyrate
  • Placebo
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Where

1 site
Neurocognition and Emotion Across Disorders (NEAD Brain Centre, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Frederiksberg Hospital
Frederiksberg, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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