Actively Recruiting
Buspirone and Melatonin for Depression Following Traumatic Brain Injury
Led by Massachusetts General Hospital · Updated on 2026-05-06
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combination of buspirone and melatonin (B+MEL) 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.
CONDITIONS
Brief Title
Buspirone and Melatonin for Depression Following Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with mild or moderate traumatic brain injury at least 3 months prior to study entry
- Age between 18 and 64 years
- Glasgow Coma Scale score between 9 and 15 within 4 hours after injury, or loss of consciousness between more than 1 minute and 24 hours, or post-traumatic amnesia less than 7 days
- English-speaking
- Current diagnosis of major depressive episode according to DSM-5
- HAM-D-21 score of 18 or higher
- Considered appropriate for buspirone and melatonin treatment by their clinician and willing to start treatment
You will not qualify if you...
- History of neurological disorders like stroke, epilepsy, multiple sclerosis, HIV, or neurodegenerative diseases
- Severe traumatic brain injury (Glasgow Coma Scale 8 or less, loss of consciousness over 24 hours, or post-traumatic amnesia over 7 days)
- Inability to attend regular appointments
- Imminent risk of suicide as determined by clinician
- Lifetime history of schizophrenia or primary psychotic disorders
- History of bipolar disorder
- Alcohol or substance dependence in the past 3 months
- Pregnancy or breastfeeding
- Use of buspirone, psychostimulants, or modafinil/armodafinil
- Current or recent antidepressant use within past 4 weeks
- Prior intolerance to buspirone or melatonin
- Conditions preventing MRI participation such as metal implants or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive buspirone 15mg once daily and melatonin 3mg once nightly to treat depression following traumatic brain injury.
Weekly visits for up to 6 weeks
Duration - Post-treatment assessments immediately following the 6-week treatment period
Participants are assessed for changes in depressive symptoms, cognitive function, and brain connectivity after treatment.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02144
Actively Recruiting
2
Massachusetts General Hospital Home Base Program
Charlestown, Massachusetts, United States, 02129
Actively Recruiting
Research Team
K
Kaloyan Tanev
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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