Recruiting

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

ClinicalTrials.gov IDNCT07404085

PhaseNA

Enrollment160

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Age40 Years

SexALL

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Conditions studied

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

About this study

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.

Interventions

Behavioral: Virtual 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.
Behavioral: Virtual 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 Supplement: HDACi butyrate — Daily intake of sodium butyrate.
Dietary Supplement: Placebo — Daily intake of placebo.

Primary outcomes

Cognitive composite measure (Baseline, week 4 (treatment completion. Primary outcome assessment time point) and week 8 (follow-up))

Eligibility information

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) * 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: * Diagnosis of schizophrenia * 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 \>30 * 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)

Study locations

Neurocognition and Emotion Across Disorders (NEAD Brain Centre, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Frederiksberg Hospital, Frederiksberg, Capital Region of Denmark 2000 Denmark

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.