Buspirone and Melatonin for Depression After Brain Injury

Buspirone and Melatonin for Depression Following Traumatic Brain Injury

Recruiting Phase 4 Interventional Study
Depression Brain Injuries, Traumatic
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 taking BuspironeAny 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.

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About This Trial
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…
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…
Contacts

Kaloyan Tanev

6177267511

ktanev@partners.org

CONTACT