Buspirone and Melatonin for Depression Following Traumatic Brain Injury
Massachusetts General Hospital
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.
Description
Background and significance: Buspirone and Melatonin Combination for the Treatment of Post-TBI Depression Traumatic brain injuries (TBIs) are common (1.7 million cases each year in the US), and major depressive disorder (MDD) occurs in up to 33% of TBI patients. 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 (15 mg/day) and melatonin (3mg), in a small outpatient cohort with MDD. Compared to the…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients with mild or moderate TBI will be included. To be included, a subject must meet the criteria below: 1. Non-penetrating mild or moderate traumatic brain injury that occurred 3 or more months prior to study entry (to minimize natural recovery from TBI) 2. Age: 18-64 years 3. Meeting any one of the following severity criteria, as documented in the patient's medical records: 1. Glasgow Coma Scale (GCS) score of 9-15 within 4 hours after injury 2. Loss of consciousness (LOC) \>1 minute and \<=24 hours 3. Post-traumatic amnesia (PTA) \< 7 days 4. English-spea…
Interventions
- DrugBuspirone
Buspirone 15mg once daily
- DrugMealatonin
Melatonin 3mg once nightly
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Massachusetts General Hospital Home Base ProgramCharlestown, Massachusetts