Magnetic Brain Stimulation for the Treatment of Adult Depression
Optimization of Transcranial Magnetic Stimulation (TMS) for Depression
2 other identifiers
interventional
190
1 country
4
Brief Summary
This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 depression
Started Feb 2005
Typical duration for phase_2 depression
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
December 28, 2018
CompletedDecember 28, 2018
December 1, 2018
4.2 years
September 6, 2005
April 8, 2016
December 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression Remission, as Measured by the Hamilton Rating Scale for Depression
The Hamilton Rating Scale for Depression 17-item total score ranges from 0 to 52 with higher scores indicating more depression. Remission is defined as a total score of ≤ 8
Measured at the end of Phases 1, 2, and 3
Study Arms (4)
Active prefrontal rTMS phase1
EXPERIMENTALPhase I participants receiving rTMS
Sham rTMS phase 1
PLACEBO COMPARATORPhase I participants receiving sham stimulation
rTMS extension
EXPERIMENTALrTMS. Phase II participants, all of whom did not meet remission requirements after phase 1. They all receive active open label rTMS
Open label antidepressant regimen
EXPERIMENTALAll patients who met remission who were then transitioned to medications after the TMS trial was completed.
Interventions
Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks.
Particpants who acheive remission with rTMS may start antidepressant medication in phase III.
The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosis of major depression with a current episode
- Hamilton Rating Scale for Depression score higher than 20
- No response or intolerance to antidepressant medication in the current depressive episode
You may not qualify if:
- Current use of antidepressants
- Diagnosis of psychosis or anxiety disorder
- Current substance abuse
- Seizures or history of head trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Emory University
Atlanta, Georgia, 30329-5102, United States
Columbia University
New York, New York, 10032, United States
Brain Stimulation Laboratory, Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Washington
Seattle, Washington, 98104-2499, United States
Related Publications (2)
Borckardt JJ, Nahas ZH, Teal J, Lisanby SH, McDonald WM, Avery D, Durkalski V, Pavlicova M, Long JM, Sackeim HA, George MS. The painfulness of active, but not sham, transcranial magnetic stimulation decreases rapidly over time: results from the double-blind phase of the OPT-TMS Trial. Brain Stimul. 2013 Nov;6(6):925-8. doi: 10.1016/j.brs.2013.04.009. Epub 2013 May 21.
PMID: 23769413DERIVEDGeorge MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
PMID: 20439832DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark S. George, MD, Professor
- Organization
- MUSC
Study Officials
- PRINCIPAL INVESTIGATOR
Mark S. George, MD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
February 1, 2005
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
December 28, 2018
Results First Posted
December 28, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
Interested researchers can email the PI, Dr. George, with a request and how they plan to analyze the data. He will then make available a de-identified copy of the data.