Buspirone and Melatonin for Depression Following Traumatic Brain Injury

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04400266
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Buspirone — DRUG
    Buspirone 15mg once daily
  • Mealatonin — DRUG
    Melatonin 3mg once nightly

Study Details

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.

Key Dates

Start date
Aug 1, 2020
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Buspirone and Melatonin
    Buspirone 15mg and Melatonin 3mg

Primary Outcome Measure

Depression [ Time Frame: 6 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02144
Kaloyan S Tanev, MD
[email protected]
617-726-7511
Mu-Yin Chang
[email protected]
(617) 283-2530
Kaloyan S Tanev, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Home Base ProgramCharlestownMassachusetts02129
Kaloyan Tanev, MD
[email protected]
617-764-6476
Mu-Yin Chang, BA
[email protected]
(617) 283-2530

Find similar trials in Boston, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Massachusetts General Hospital· Boston, MAMassachusetts General Hospital Home Base Program· Charlestown, MA

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