Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT07404085

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

Led by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Updated on 2026-02-11

160

Participants Needed

1

Research Sites

137 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of bipolar disorder or recurrent major depressive disorder in partial or full remission with low depression and mania scores (≤14 on HDRS-17 and YMRS)
  • Self-reported cognitive complaints or objectively verified cognitive impairment
  • Fluent in Danish language
Not Eligible

You will not qualify if you...

  • 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
  • Body Mass Index over 30
  • Body weight less than 45 kg
  • Daily benzodiazepine use exceeding specified doses
  • Serum lithium levels above 0.8 mmol/L
  • Electroconvulsive therapy within 2 months prior to participation
  • High blood pressure (systolic >140 or diastolic >90 mm Hg)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

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, 2000

Actively Recruiting

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Research Team

B

Bjørn Ole Barkholt Nordseth, Ph.D.-student

CONTACT

K

Kamilla Woznica Miskowiak, DMSc, DPhil

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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