Boston, MANCT04400266Now EnrollingIRB Ready

Depression Following Traumatic Brain Injury Clinical Trial in Boston, MA

Access cutting-edge depression following traumatic brain injury treatment through this phase 4 clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Massachusetts General Hospital

Quick Self-Assessment

See if you qualify for this Boston location

Preparing your pre-screening questions…

Expert Care in Boston

Access depression following traumatic brain injury specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related depression following traumatic brain injury treatment provided free

Apply for This Boston Location

Check if you qualify for this depression following traumatic brain injury clinical trial in Boston, MA

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Depression Following Traumatic Brain Injury Study in Boston

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 c

Sponsor: Massachusetts General Hospital

Who Can Participate

Inclusion Criteria

Patients with mild or moderate TBI will be included. To be included, a subject must meet the criteria below:
Non-penetrating mild or moderate traumatic brain injury that occurred 3 or more months prior to study entry (to minimize natural recovery from TBI)
Age: 18-64 years
Meeting any one of the following severity criteria, as documented in the patient's medical records:
Glasgow Coma Scale (GCS) score of 9-15 within 4 hours after injury
Loss of consciousness (LOC) \>1 minute and \<=24 hours
Post-traumatic amnesia (PTA) \< 7 days
English-speaking
Current DSM-5 diagnosis of Major Depressive Episode by medical record diagnosis
HAM-D-21 score of 18 or higher
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

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.
Evidence from the history of TBI severity greater than moderate, i.e., GCS of 8 or less, LOC \> 24 hours, or PTA \> 7 days.
Inability to attend regular appointments
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.
Lifetime history of schizophrenia or other primary psychotic disorders, as determined by history by the patient or review of their medical records.
History of bipolar disorder, as determined by history by the patient or review of their medical records.
Alcohol or substance dependence in the past 3 months, as determined by history by the patient or review of their medical records.
Pregnancy or breast-feeding
Concomitant use of buspirone, any psychostimulant, or modafinil/armodafinil
Patients currently on an antidepressant or who have been on antidepressant in the past 4 weeks
Patients with prior intolerances to buspirone or melatonin.
Conditions that would preclude a subject from participating in the MRI procedures (e.g., metal implants, aneurysm clips, shrapnel/retained particles, pacemakers, claustrophobia).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT04400266) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Depression Following Traumatic Brain Injury Treatment Options in Boston, MA

If you're searching for depression following traumatic brain injury treatment options in Boston, MA, this clinical trial (NCT04400266) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced depression following traumatic brain injury specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all depression following traumatic brain injury clinical trials near you to find additional studies recruiting in your area.

More Traumatic Brain Injury Trials in Boston, MA

See all traumatic brain injury clinical trials recruiting in Boston — not just this study.

Browse Traumatic Brain Injury Trials in Boston →

Browse More Trials by Condition

Traumatic Brain Injury TrialsDepression TrialsRheumatoid Arthritis TrialsInterstitial Cystitis TrialsAll Conditions →

Ready to Join in Boston?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Boston, MA