Clinical Research Directory

Midday Bright Light Therapy for Bipolar Depression

This randomized, double-blind, placebo-controlled study evaluated adjunctive midday bright light therapy in adults with bipolar I or II disorder experiencing mild-to-moderate depression. Participants received either 10,000-lux bright light or 1,500-lux placebo light at home for 30 minutes daily between 12:00 PM and 2:00 PM for four weeks while continuing unchanged pharmacological treatment. The primary outcome was remission at week 4, defined as a total score below 9 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version. Secondary outcomes included clinical status, psychosocial functioning, sleep quality, circadian characteristics, and adverse effects.

Testing a New Gold Nanoparticle-Based Lithium Delivery Method for Bipolar Disorder in Laboratory Models

This preclinical translational study aims to evaluate a new method of delivering lithium using gold nanoparticles for the treatment of bipolar disorder. Lithium is an effective treatment for bipolar disorder, but its clinical use is limited by a narrow therapeutic range and the risk of side effects. The study will investigate whether gold nanoparticles carrying lithium can improve lithium delivery to brain cells while reducing exposure to other tissues. The research will use human induced pluripotent stem cell (iPSC)-derived neural cells generated from blood samples collected from people with bipolar disorder and healthy volunteers, as well as a mouse model of mania. No participants will receive the investigational treatment. Human participants will provide blood samples only for the generation of laboratory cell models. The study will compare the effects of nanoparticle-delivered lithium with conventional lithium salts on cellular lithium uptake, disease-related molecular and functional changes, and biomarkers associated with bipolar disorder. The hypothesis is that lithium delivered by gold nanoparticles will achieve greater therapeutic effects at lower systemic lithium exposure than conventional lithium formulations, providing proof of concept for a safer and more targeted lithium delivery strategy for future clinical development.

Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device

The study aims to verify if the Gaize ocular device can effectively identify eye movements indicative of prescribed psychotropic medication usage by employing Drug Recognition Expert (DRE) testing protocols within a controlled virtual environment.