Study of Virtual Reality Cognitive Training and Sodium Butyrate to Improve Thinking in Adults 40 to 75 with Stable Depression or Bipolar Disorder

What this Trial Is About

Researchers are studying middle-aged to older adults 40 to 75 years with stable mood disorders, including major depressive disorder or bipolar disorder, to understand how a combination of virtual reality-based cognitive training and a dietary supplement called sodium butyrate affects cognition. The trial aims to see if this combined approach improves overall cognitive function and brain plasticity better than either treatment alone or placebo. The study also explores changes in brain structure and activity using MRI scans. Participants are randomly assigned to one of four groups for three weeks high-intensity virtual reality cognitive remediation therapy VR-CRT with sodium butyrate, VR-CRT with placebo, low-intensity virtual reality control treatment VR-CT with sodium butyrate, or VR-CT with placebo. VR-CRT involves weekly sessions with a therapist and daily cognitive exercises in virtual scenarios like kitchens and supermarkets, while VR-CT includes weekly sessions playing simple virtual games without targeted cognitive training. Daily intake of sodium butyrate or placebo supplements is combined with these virtual reality programs. Participants undergo detailed assessments at baseline, after treatment completion at four weeks, and at an eight-week follow-up. These include virtual reality cognition tests, comprehensive neuropsychological batteries, questionnaires on cognitive complaints and quality of life, clinical interviews, and sleep evaluations. Brain scans during functional MRI tasks related to memory and emotion are performed before and after treatment. Researchers will measure changes in cognitive performance, memory, psychosocial function, and brain imaging outcomes to evaluate the effects of the treatments.

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