Buspirone and Melatonin for Depression Following Traumatic Brain Injury
Status:
Not yet recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
Summary
Traumatic brain injuries (TBIs) are common. Post-TBI depression is associated with anxiety,
aggression, fatigue, distractibility, anger, irritability, and rumination. The current
research group conducted a pilot clinical trial, which investigated the novel treatment
combination of buspirone and melatonin (B+MEL) in outpatients with clinical depression.
Compared to placebo, B+MEL was associated with a significant improvement in depressive
symptoms. Depression following TBI may be different from clinical depression. The B+MEL
combination has never been studied in patients with post-TBI depression. The B+MEL has shown
promise in ameliorating cognitive difficulties in people with depression. Because cognitive
problems are typical in people with post-TBI depression, we plan to measure the effect of the
B+MEL combination on cognitive ability in post-TBI depression. Additionally, we are
interested in measuring functional magnetic resonance imaging changes before and after
treatment with B+MEL in order to gain insight into the brain mechanisms of our hypothesized
clinical symptom changes.
The goals of the proposed pilot research project are to assess changes in symptoms in
patients with post-TBI depression following Buspirone + Melatonin combination (B+MEL), and
the corresponding brain mechanisms underlying these hypothesized changes by measuring: 1)
depressive symptoms; 2) cognitive symptoms; 3) functional magnetic resonance imaging.