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.
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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

Kaloyan Tanev

6177267511

ktanev@partners.org

CONTACT