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Buspirone and Melatonin for Depression Following Traumatic Brain Injury

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Jul 31, 2026 to Jul 31, 2028v3
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jul 31, 2021 to Jul 31, 2026 · Study sites: 1 to 2 · Completion date: Jul 31, 2022 to Jul 31, 2026 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Jul 31, 2021 to Jul 31, 2026
    • Study sites: 1 to 2
    • Completion date: Jul 31, 2022 to Jul 31, 2026
    • Interventions: B+MEL (Drug) to Buspirone (Drug), Mealatonin (Drug)
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. The B+MEL combination has never been studied in patients with post-TBI depression. The B+MEL has shown promise in ameliorating cognitive difficulties in people with depression. Because cognitive problems are typical in people with post-TBI depression, we plan to measure the effect of the B+MEL combination on cognitive ability in post-TBI depression. Additionally, we are interested in measuring functional magnetic resonance imaging changes before and after treatment with B+MEL in order to gain insight into the brain mechanisms of our hypothesized clinical symptom changes. The goals of the proposed pilot research project are to assess changes in symptoms in patients with post-TBI depression following Buspirone + Melatonin combination (B+MEL), and the corresponding brain mechanisms underlying these hypothesized changes by measuring: 1) depressive symptoms; 2) cognitive symptoms; 3) functional magnetic resonance imaging.
Trial Details
NCT Number NCT04400266
Lead Sponsor Massachusetts General Hospital
Conditions Depression, Brain Injuries, Traumatic
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov