Buspirone and Melatonin for Depression Following Traumatic Brain Injury
Recruiting
Phase 4
Interventional Study
Depression
Brain Injuries, Traumatic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 64
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- Massachusetts General Hospital · Other
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About This Trial
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 wit…
Trial Locations
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Eligibility Criteria
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 year…
Contacts