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Could a common anxiety drug and melatonin lift depression after brain injury?

NCT ID NCT04400266

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small pilot study tests whether a combination of buspirone (an anxiety medication) and melatonin (a sleep aid) can improve depression and thinking problems in people who have had a traumatic brain injury. Ten adults with mild or moderate TBI and depression will take the combination for several weeks. Researchers will measure changes in mood, cognition, and brain activity using scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
buspirone and melatonin
What this could lead to
If it works, this could point toward a new treatment option for depression and cognitive problems after traumatic brain injury.
What could go wrong
This is a very small pilot study with only 10 participants, so results may not apply widely. The combination has not been tested specifically for post-TBI depression before, and benefits may be modest or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Depression depressive disorder traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02144, United States

  • Massachusetts General Hospital Home Base Program

    RECRUITING

    Charlestown, Massachusetts, 02129, United States

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