RecruitingPhase 4NCT04400266

Buspirone and Melatonin for Depression Following Traumatic Brain Injury


Sponsor

Massachusetts General Hospital

Enrollment

10 participants

Start Date

Aug 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether two medications — buspirone (an anti-anxiety drug) and melatonin (a sleep aid) — can help treat depression in people who have had a mild or moderate traumatic brain injury (TBI, a head injury). **You may be eligible if...** - You had a mild or moderate head injury at least 3 months ago (not a penetrating injury) - You are between 18 and 64 years old - You speak English - You have been diagnosed with major depression - Your depression symptoms are moderate to severe based on a standard rating scale - Your doctor thinks these medications are appropriate for you **You may NOT be eligible if...** - You have another neurological condition such as stroke, epilepsy, or multiple sclerosis - Your brain injury was severe (long loss of consciousness or memory loss) - You currently take antidepressants or have taken them in the last 4 weeks - You are pregnant or breastfeeding - You have schizophrenia, bipolar disorder, or recent substance dependence - You cannot have an MRI (e.g., have metal implants or severe claustrophobia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBuspirone

Buspirone 15mg once daily

DRUGMealatonin

Melatonin 3mg once nightly


Locations(2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital Home Base Program

Charlestown, Massachusetts, United States

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NCT04400266


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