Buspirone and Melatonin for Depression After Traumatic Brain Injury

This study is looking at whether a combination of two existing medications, buspirone and melatonin, can help people who experience depression after a traumatic brain injury (TBI). Previous research suggests this combination might improve depressive symptoms in people with general depression, and also help with thinking difficulties. This study will give participants either 15mg of buspirone once daily and 3mg of melatonin once nightly. Researchers will measure changes in depression symptoms after 6 weeks to see if the treatment is effective. You may be able to join if you are between 18 and 64 years old and had a mild or moderate TBI at least three months ago. The study plans to enroll 10 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Depression symptoms will be measured at 6 weeks after starting treatment.

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NCT04400266

Buspirone and Melatonin for Depression Following Traumatic Brain Injury

Recruiting
PHASE4Ages 18–64InterventionalTreatment
Massachusetts General Hospital
~10 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:BuspironeMealatonin

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Depression
Measured over 6 weeks
Depression
Brain Injuries, Traumatic
2 sites across 1 states
Massachusetts2

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  • Depression6 weeks

    Hamilton Depression Rating Scale (HDRS); Min. value: 0; Max, value: 62; Higher number indicates higher severity of symptoms.