Using an epigenetic drug to boost virtual reality cognitive training for middle-aged and older adults with depression or bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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)

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.