RecruitingNot ApplicableNCT07404085

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

Epigenetic Priming to Enhance Cognitive Training Gains and Neuroplasticity in Middle-age and Older Adults With Past Depression or Bipolar Disorder (EPIC)

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Enrollment

160 participants

Start Date

Nov 14, 2025

Study Type

INTERVENTIONAL

Conditions

Cognitive Impairment Depression - Major Depressive Disorder Bipolar Disorder (BD)

Summary

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 disorders (depression or bipolar disorder). 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.

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication that affects gene activity (called an epigenetic drug) can boost the results of cognitive training in older people with bipolar disorder or recurrent depression who are experiencing memory and thinking problems. **You may be eligible if...** - You have a confirmed diagnosis of bipolar disorder or recurrent unipolar depression and are currently in partial or full remission - You have noticeable cognitive difficulties — either self-reported or measured by testing - You can read and understand Danish **You may NOT be eligible if...** - You have schizophrenia or another psychotic disorder - You have a neurological condition such as dementia or epilepsy - You have dyslexia - You have serious physical illness, kidney disease, cardiovascular disease, or diabetes - You have a history of alcohol or substance abuse - You are pregnant or breastfeeding - Your BMI is over 30 or you weigh less than 45 kg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALVirtual Reality-based cognitive remediation therapy (VR-CRT)

VR-CRT on 360° Meta Quest 2-software in which participants train cognitive abilities guided by a therapist. The platform includes three immersive scenarios: (1) a kitchen scenario focusing on planning and cooking a meal, (2) a supermarket scenario focusing on grocery shopping and (3) a restaurant scenario focusing on remembering names and personal information. The virtual reality training is supported by a psychoeducation program that focuses on application of learned cognitive strategies in daily life.

BEHAVIORALVirtual Reality-based control treatment (VR-CT)

VR-CT: The virtual reality control training involves completing different virtual reality games that are available through the Meta Quest games store. The chosen games involve no direct training of cognitive abilities such as planning skills og strategic learning, but merely involves simple reaction time and interaction with an entertaining environment that is meaningful to the participant and gives the impression of training cognitive skills.

DIETARY_SUPPLEMENTHDACi butyrate

Daily intake of sodium butyrate.

DIETARY_SUPPLEMENTPlacebo

Daily intake of placebo.

Locations(1)

Neurocognition and Emotion Across Disorders (NEAD Brain Centre, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Frederiksberg Hospital

Frederiksberg, Capital Region of Denmark, Denmark

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NCT07404085