Buspirone and Melatonin for Depression Following Traumatic Brain Injury
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.
∙ Patients with mild or moderate TBI will be included. To be included, a subject must meet the criteria below:
• Non-penetrating mild or moderate traumatic brain injury that occurred 3 or more months prior to study entry (to minimize natural recovery from TBI)
• Age: 18-64 years
• Meeting any one of the following severity criteria, as documented in the patient's medical records:
‣ Glasgow Coma Scale (GCS) score of 9-15 within 4 hours after injury
⁃ Loss of consciousness (LOC) \>1 minute and \<=24 hours
⁃ Post-traumatic amnesia (PTA) \< 7 days
• English-speaking
• Current DSM-5 diagnosis of Major Depressive Episode by medical record diagnosis
• HAM-D-21 score of 18 or higher
• Patients who are considered to be appropriate by their clinician and who are willing to be started on Buspirone and Melatonin for clinical purposes.