Back to resultsCircuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
Primary Purpose
Major Depressive Disorder, Borderline Personality Disorder, Suicide
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)
Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Transcranial Magnetic Stimulation, Intermittent Theta Burst
Eligibility Criteria
Inclusion Criteria:
- 18-60 years of age
- Diagnosed with BPD or MDD
- Chief complaint of suicidal thoughts and behaviors
- Ownership of smart phone (e.g., Android, Apple)
- Permission to use smart phone during an inpatient stay
Exclusion Criteria:
- History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae.
- Prior neurosurgical procedure.
- Metal in the body that is ferromagnetic or metal injury to the eyes.
- History of seizures.
- Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, or ventriculo-peritoneal shunt.
- Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis).
- Substance abuse or dependence that is current or within the last six months, as indicated by self-report.
- Inability to meet the safety criteria for MRI scanning according to the protocols of the Department of Radiology.
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
Sham Comparator
Arm Label
MDD and Active iTBS-TMS
BPD and Active iTBS-TMS
MDD and Sham iTBS-TMS
BPD and Sham iTBS-TMS
Arm Description
This group will consist of patients diagnosed with MDD that are receiving active iTBS-TMS.
This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.
This group will consist of patients diagnosed with MDD that are receiving sham iTBS-TMS.
This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.
Outcomes
Primary Outcome Measures
Changes in Functional Connectivity of Key Nodes
Measured using Magnetic Resonance Imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT04130958
First Posted
October 16, 2019
Last Updated
March 1, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04130958
Brief Title
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
Official Title
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive disorder (MDD) and borderline personality disorder (BPD).
Detailed Description
This neuroimaging study aims to determine the effectiveness of iTBS-TMS to the IPL in reducing suicide risk in patients with MDD and BPD. This study also aims to identify the structural and functional circuit properties that characterized the suicidal brain and the signatures that explain the clinical severity of suicidal risk. Moreover, this study aims to determine biological and dimensional predictors of anti-suicidal response to iTBS-TMS and its mechanism of action.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Borderline Personality Disorder, Suicide
Keywords
Transcranial Magnetic Stimulation, Intermittent Theta Burst
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MDD and Active iTBS-TMS
Arm Type
Experimental
Arm Description
This group will consist of patients diagnosed with MDD that are receiving active iTBS-TMS.
Arm Title
BPD and Active iTBS-TMS
Arm Type
Experimental
Arm Description
This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.
Arm Title
MDD and Sham iTBS-TMS
Arm Type
Sham Comparator
Arm Description
This group will consist of patients diagnosed with MDD that are receiving sham iTBS-TMS.
Arm Title
BPD and Sham iTBS-TMS
Arm Type
Sham Comparator
Arm Description
This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.
Intervention Type
Device
Intervention Name(s)
Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)
Other Intervention Name(s)
Active iTBS-TMS
Intervention Description
iTBS-TMS is a noninvasive neuromodulation technique that uses a powerful magnet to induce focal electrical currents in target brain regions.
Intervention Type
Device
Intervention Name(s)
Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)
Other Intervention Name(s)
Sham iTBS-TMS
Intervention Description
The sham version of iTBS-TMS involves placing the magnet over the same target brain region but the device will not be turned on during the treatment. There will be two electrodes placed on the scalp that mimic the sensation of iTBS-TMS but does not induce focal electrical currents.
Primary Outcome Measure Information:
Title
Changes in Functional Connectivity of Key Nodes
Description
Measured using Magnetic Resonance Imaging
Time Frame
Through Treatment Completion, Average of 3 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-60 years of age
Diagnosed with BPD or MDD
Chief complaint of suicidal thoughts and behaviors
Ownership of smart phone (e.g., Android, Apple)
Permission to use smart phone during an inpatient stay
Exclusion Criteria:
History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae.
Prior neurosurgical procedure.
Metal in the body that is ferromagnetic or metal injury to the eyes.
History of seizures.
Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, or ventriculo-peritoneal shunt.
Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis).
Substance abuse or dependence that is current or within the last six months, as indicated by self-report.
Inability to meet the safety criteria for MRI scanning according to the protocols of the Department of Radiology.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DNN Inbox
Phone
6177248780
Email
mghdnn@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Camprodon, MD/PhD
Organizational Affiliation
6177265348
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DNN Inbox
Phone
617-724-8780
Email
mghdnn@mgh.harvard.edu
12. IPD Sharing Statement
Learn more about this trial
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
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