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NCT04400266 · ClinicalTrials.gov registry record · Phase 4
Buspirone and Melatonin for Depression Following Traumatic Brain Injury
A Phase 4 study of Depression and Brain Injuries, Traumatic, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT04400266: Recruiting Phase 4 study of Depression and Brain Injuries, Traumatic, sponsored by Massachusetts General Hospital.
NCT04400266 is a Phase 4 study of Depression and Brain Injuries, Traumatic that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 10 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04400266, a Phase 4 study of Depression and Brain Injuries, Traumatic, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study 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. 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.
Primary Outcome
Hamilton Depression Rating Scale (HDRS); Min. value: 0; Max, value: 62; Higher number indicates higher severity of symptoms.
Conditions Studied
Interventions
- DRUG Buspirone
- DRUG Mealatonin
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Massachusetts General Hospital Home Base Program - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 4 |
What NCT04400266 shows while recruiting
NCT04400266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Buspirone is the first listed.
NCT04400266 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04400266 about?
NCT04400266 is a clinical study titled "Buspirone and Melatonin for Depression Following Traumatic Brain Injury". 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 mela...
What is the current status of trial NCT04400266?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2020-08-01. Estimated completion is 2026-07-31.
What conditions does trial NCT04400266 study?
This clinical trial studies the following conditions: Depression, Brain Injuries, Traumatic.
What interventions are being tested in trial NCT04400266?
The interventions under investigation include: Buspirone (DRUG), Mealatonin (DRUG).
Who is sponsoring clinical trial NCT04400266?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04400266 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04400266's enrollment target sits among peer trials
10 659th of 679 higher than 17 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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