Could a common anxiety drug and melatonin lift depression after brain injury?

NCT ID NCT04400266

Recruiting now Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small pilot study tests whether a combination of buspirone (an anxiety medication) and melatonin (a sleep aid) can improve depression and thinking problems in people who have had a traumatic brain injury. Ten adults with mild or moderate TBI and depression will take the combination for several weeks. Researchers will measure changes in mood, cognition, and brain activity using scans.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: buspirone and melatonin
What this could lead to: If it works, this could point toward a new treatment option for depression and cognitive problems after traumatic brain injury.
What could go wrong: This is a very small pilot study with only 10 participants, so results may not apply widely. The combination has not been tested specifically for post-TBI depression before, and benefits may be modest or absent.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Depression depressive disorder traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRAIN INJURIES, TRAUMATIC DEPRESSION

Contacts and locations

Locations

Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02144, United States
Massachusetts General Hospital Home Base Program
RECRUITING

Charlestown, Massachusetts, 02129, United States

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