Buspirone and Melatonin for Depression Following Traumatic Brain Injury
NCT04400266
This study is recruiting at 2 US sites in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Depression
- Brain Injuries, Traumatic
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 4
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Massachusetts General Hospital
- Last updated on ClinicalTrials.gov
- May 6, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Massachusetts · 2
- Massachusetts General Hospital · Boston, MA
- Massachusetts General Hospital Home Base Program · Charlestown, MA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.