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Buspirone + Melatonin for Depression After Traumatic Brain Injury

Phase 4
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is investigating the effectiveness of a novel treatment combination of Buspirone and Melatonin (B+MEL) in outpatients with clinical depression who have also suffered a traumatic brain injury (TBI). The trial will measure changes in depressive symptoms, cognitive symptoms, and brain activity before and after treatment.

Who is the study for?
This trial is for adults aged 18-64 who have had a non-penetrating mild or moderate traumatic brain injury at least 3 months ago, with specific scores on the Glasgow Coma Scale and experiences of loss of consciousness and post-traumatic amnesia. They must be experiencing depression as diagnosed by medical records, speak English, and have a certain score indicating depression severity.
What is being tested?
The study tests Buspirone combined with Melatonin (B+MEL) in outpatients suffering from depression after a traumatic brain injury. It aims to see if this combination improves depressive and cognitive symptoms while also looking at changes in brain function through imaging before and after treatment.
What are the potential side effects?
While not explicitly stated here, common side effects of Buspirone can include dizziness, nausea, headache, nervousness; Melatonin may cause drowsiness or sleepiness. Side effects might vary based on individual health conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Depression
Secondary study objectives
Cognition
Other study objectives
Functional neuroimaging

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Buspirone and MelatoninExperimental Treatment2 Interventions
Buspirone 15mg and Melatonin 3mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
2022
Completed Phase 4
~1160

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,801 Total Patients Enrolled
~3 spots leftby Jul 2026
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