Buspirone and Melatonin for treating depression after brain injuries

Buspirone and Melatonin for Depression Following Traumatic Brain Injury

This study is testing if a mix of buspirone and melatonin can help people with depression after a traumatic brain injury feel better and improve their thinking skills.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT04400266 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a combination of buspirone and melatonin in treating depression in patients who have experienced traumatic brain injuries (TBIs). The study aims to assess the impact of this treatment on depressive symptoms and cognitive abilities, as well as to explore changes in brain function using functional magnetic resonance imaging. Participants will include individuals with mild to moderate TBIs who meet specific criteria related to their injury and depression severity. The trial builds on previous findings that suggest this combination may improve depressive symptoms in a broader population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-64 with mild to moderate TBIs and a current diagnosis of major depressive episode.

Not a fit: Patients with severe neurological disorders or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from depression following traumatic brain injuries.

How similar studies have performed: While the combination of buspirone and melatonin has shown promise in other populations, this specific application in post-TBI depression is novel and has not been previously tested.

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 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).

Where this trial is running

Boston, Massachusetts and 1 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Massachusetts General Hospital Home Base Program — Charlestown, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Kaloyan Tanev

Conditions Depression; Brain Injuries, Traumatic