Using an epigenetic drug to boost virtual reality cognitive training for middle-aged and older adults with depression or bipolar disorder
Epigenetic Priming to Enhance Cognitive Training Gains and Neuroplasticity in Middle-age and Older Adults With Past Depression or Bipolar Disorder (EPIC)
This trial will test whether daily sodium butyrate combined with three weeks of virtual reality cognitive training improves thinking skills in symptomatically stable adults aged 40–75 with depression or bipolar disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital Academic / other |
| Locations | 1 site (Frederiksberg, Capital Region of Denmark) |
| Trial ID | NCT07404085 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind interventional study will enroll up to 160 participants to obtain complete data on 120 adults (40–75) with major depressive disorder or bipolar disorder in full or partial remission who have subjective or objective cognitive complaints. Participants are randomized to four arms for three weeks: VR-based cognitive remediation training (VR-CRT) with sodium butyrate, VR-CRT with placebo, VR control treatment with sodium butyrate, or VR control with placebo. Outcomes include a global cognition composite as the primary endpoint, a comprehensive neuropsychological battery, VR-based cognitive testing, patient-reported cognition and quality of life measures, and fMRI during cognitive tasks. The main hypothesis is that combining an HDAC inhibitor (sodium butyrate) with VR-CRT will produce greater improvements in global cognition than the other combinations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40–75 with major depressive disorder or bipolar disorder who are in full or partial remission, fluent in Danish, and who report subjective cognitive complaints or show objective cognitive impairment on screening.
Not a fit: Patients with neurological disorders (including dementia), active substance abuse, significant medical comorbidities (e.g., uncontrolled cardiovascular, kidney disease, diabetes), BMI >30, pregnancy or breastfeeding, or those unable to attend in-person visits in Copenhagen are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could provide a meaningful improvement in overall cognitive function and daily functioning for middle-aged and older adults with mood disorders.
How similar studies have performed: Preclinical studies show HDAC inhibitors like sodium butyrate can enhance neuroplasticity and cognitive training programs have shown modest benefit in mood disorders, but combining an HDAC inhibitor with VR cognitive remediation in humans is largely novel with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Frederiksberg, Capital Region of Denmark
- 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 (Recruiting)
Study contacts
- Principal investigator: Kamilla Woznica Miskowiak, DMSc, DPhil — Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study coordinator: Bjørn Ole Barkholt Nordseth, Ph.D.-student
- Email: bjoern.ole.barkholt.nordseth@regionh.dk
- Phone: +4527134653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.