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Buspirone and Melatonin for Depression Following Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04400266
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Information provided by (Responsible Party):
Kaloyan Tanev, MD, Massachusetts General Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Depression Brain Injuries, Traumatic Drug: B+MEL Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single-arm, open-label study of the Buspirone and Melatonin combination administered over 6 weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buspirone and Melatonin for Depression Following Traumatic Brain Injury
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Buspirone and Melatonin
Buspirone 15mg and Melatonin 3mg
Drug: B+MEL
Buspirone and Melatonin

Primary Outcome Measures :
  1. Depression [ Time Frame: 6 weeks ]
    Hamilton Depression Rating Scale - 21 item

Secondary Outcome Measures :
  1. Cognition [ Time Frame: 6 weeks ]
    NIH-Toolbox Cognition Battery Fluid Cognition Composite Score

Other Outcome Measures:
  1. Functional neuroimaging [ Time Frame: 6 weeks ]
    fMRI resting state functional connectivity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04400266

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Contact: Kaloyan Tanev 6177267511

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02144
Sponsors and Collaborators
Massachusetts General Hospital
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Responsible Party: Kaloyan Tanev, MD, Associate psychiatrist, Massachusetts General Hospital Identifier: NCT04400266    
Other Study ID Numbers: 2019P003783
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Depressive Disorder
Wounds and Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System