Study of Buspirone and Melatonin Treatment for Depression After Mild to Moderate Traumatic Brain Injury in Adults 18 to 64

What this Trial Is About

Researchers are studying the combination of buspirone and melatonin BMEL to treat depression that occurs after a traumatic brain injury TBI. Post-TBI depression often includes symptoms like anxiety, aggression, fatigue, and irritability and may differ from general clinical depression. This study aims to evaluate changes in depressive and cognitive symptoms and explore brain activity changes using functional magnetic resonance imaging fMRI. Participants will receive buspirone 15 mg once daily and melatonin 3 mg once nightly. This trial investigates how this combination affects depression and cognitive function in people who have experienced mild to moderate TBI at least three months prior. The study will also use brain scans to observe changes in resting state functional connectivity related to treatment. During the study, participants will be assessed for changes in depressive symptoms using the HAM-D scale and cognitive abilities such as verbal memory, executive function, and processing speed. Brain imaging will be conducted before and after treatment to examine brain network activity. The total participation involves regular appointments over a 6-week treatment period, during which symptoms and brain function will be closely monitored.

Buspirone and Melatonin for Depression Following Traumatic Brain Injury