No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 64
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for adults aged 18-64 who have depression after a mild or moderate traumatic brain injury. Participants will take a combination of buspirone and melatonin and will be monitored for changes in their symptoms and brain activity.
Are You a Good Fit for This Trial?
Must not be takingBuspironeAny antidepressants
You may be able to join if
I am aged 18-64 years
I have had a mild or moderate traumatic brain injury at least 3 months ago
I have been diagnosed with a Major Depressive Episode
I have a HAM-D-21 score of 18 or higher
I speak English
My doctor believes I can start treatment with buspirone and melatonin
You may not be able to join if
I have a history of severe neurological disorders
I have had a traumatic brain injury that was more than moderate
I cannot attend regular appointments
I am at immediate risk of suicide
I have a lifetime history of schizophrenia or psychotic disorders
I have a history of bipolar disorder
I have had alcohol or substance dependence in the past 3 months
I am pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 wit…
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 Locations
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Eligibility Criteria
Inclusion Criteria:
Patients with mild or moderate TBI will be included. To be included, a subject must meet the criteria below:
1. Non-penetrating mild or moderate traumatic brain injury that occurred 3 or more months prior to study entry (to minimize natural recovery from TBI)
2. Age: 18-64 year…
Inclusion Criteria:
Patients with mild or moderate TBI will be included. To be included, a subject must meet the criteria below:
1. Non-penetrating mild or moderate traumatic brain injury that occurred 3 or more months prior to study entry (to minimize natural recovery from TBI)
2. Age: 18-64 years
3. Meeting any one of the following severity criteria, as documented in the patient's medical records:
1. Glasgow Coma Scale (GCS) score of 9-15 within 4 hours after injury
2. Loss of consciousness (LOC) \>1 minute and \<=24 hours
3. Post-traumatic amnesia (PTA) \< 7 days
4. English-speaking
5. Current DSM-5 diagnosis of Major Depressive Episode by medical record diagnosis
6. HAM-D-21 score of 18 or higher
7. Patients who are considered to be appropriate by their clinician and who are willing to be started on Buspirone and Melatonin for clinical purposes.
Exclusion Criteria:
1. History of neurological disorder (e.g., stroke, epilepsy, multiple sclerosis, HIV, neurodegenerative disorders) or any acute or unstable medical condition that is likely to interfere with the assessments or with participation in treatment, as determined by history by the patient or review of their medical records.
2. Evidence from the history of TBI severity greater than moderate, i.e., GCS of 8 or less, LOC \> 24 hours, or PTA \> 7 days.
3. Inability to attend regular appointments
4. Imminent risk of suicide, as determined by the assessing clinician; HAM-D, Question 3, answers \> 1; SDQ, Question 11, answers \> 3; spontaneous expressions of suicidal ideation will result in emergency evaluation by a licensed clinician member of study staff for appropriate assessment and triage.
5. Lifetime history of schizophrenia or other primary psychotic disorders, as determined by history by the patient or review of their medical records.
6. History of bipolar disorder, as determined by history by the patient or review of their medical records.
7. Alcohol or substance dependence in the past 3 months, as determined by history by the patient or review of their medical records.
8. Pregnancy or breast-feeding
9. Concomitant use of buspirone, any psychostimulant, or modafinil/armodafinil
10. Patients currently on an antidepressant or who have been on antidepressant in the past 4 weeks
11. Patients with prior intolerances to buspirone or melatonin.
12. Conditions that would preclude a subject from participating in the MRI procedures (e.g., metal implants, aneurysm clips, shrapnel/retained particles, pacemakers, claustrophobia).
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