Antidepressant Mechanisms of Transcranial Magnetic Stimulation
Predictive and Response Biomarkers of Effective Treatment With Transcranial Magnetic Stimulation for Major Depressive Disorder
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A history of major depressive disorder by the Structured Clinical Interview for DSM-IV (SCID)
- Failure to respond to at least two previous antidepressant trials at adequate doses for 8 weeks (for current or prior major depressive episodes)
- A minimum 17-item Hamilton depression rating scale of 17 on both the screening day and the treatment day #1
- Age 18-70
- Participants may be taking antidepressants, antipsychotics, or low-dose mood stabilizers during the study
- Participants may be in psychotherapy during the study
Exclusion Criteria:
- Participants with metal implants (Will use the NY Presbyterian Hospital MRI Checklist)
- Prior exposure to TMS
- Pregnant women
- Lactating women
- Bipolar disorder (on the Structured Clinical Interview for DSM-IV (SCID)
- Current depressive episode longer than 3 years
- Active suicidal ideation with plan or intent
- Borderline personality disorder (on the Structured Clinical Interview for DSM-IV (SCID)
- Substance abuse or dependence with the past 3 years
- Current urine drug screen positive for any drugs of abuse
- Current symptoms of psychosis
- History of seizure disorder
- History of closed head injury with loss of consciousness
- History of brain surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Active rTMS
Subjects in the active rTMS arm will receive daily active repetitive transcranial magnetic stimulation (rTMS) treatments for 25 days (Monday through Friday for 5 consecutive weeks).
Active rTMS with the FDA approved Neuronetics TMS system will be administered.
Each treatment will target the left dorsolateral prefrontal cortex.
rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.
|
Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks).
Active rTMS with the FDA approved Neuronetics TMS system.
Each treatment will target the left dorsolateral prefrontal cortex.
rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression Severity Measured by the Hamilton Depression Rating Scale (24-Item)
Time Frame: Change in score on Hamilton Depression Rating Scale from baseline to immediately after the final rTMS treatment (5 weeks)
|
The Hamilton Depression Rating Scale is 24 items with total scores ranging from 0-76.
Higher scores indicate greater severity of depression.
(0-7 = None; 8-13 = Mild; 14-18 = Moderate; 19-23 = Severe; 23 and higher = very severe).
Total scores are reported with no subscales.
|
Change in score on Hamilton Depression Rating Scale from baseline to immediately after the final rTMS treatment (5 weeks)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression Severity Measured by the Public Health Questionnaire-9
Time Frame: Change in score in Public Health Questionnaire-9 from baseline to immediately after the final rTMS treatment (5 weeks)
|
Self-rated scale of symptoms of depression.
Nine items with a maximum score of 27.
Higher score means more severe depression (0-4 = None; 5-9 = Mild; 10-14 = Moderate; 15-19 = Severe; 20 and higher = Very Severe).
|
Change in score in Public Health Questionnaire-9 from baseline to immediately after the final rTMS treatment (5 weeks)
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gamma-amino-butyric Acid Level Measured by Magnetic Resonance Spectroscopy
Time Frame: Baseline to immediately after the final rTMS treatment (5 weeks)
|
Percent change in medial prefrontal gamma-amino-butyric acid level
|
Baseline to immediately after the final rTMS treatment (5 weeks)
|
|
Glutamate Level Measured by Magnetic Resonance Spectroscopy
Time Frame: Baseline to immediately after the final rTMS treatment (5 weeks)
|
Percent change in medial prefrontal glutamate level
|
Baseline to immediately after the final rTMS treatment (5 weeks)
|
|
Cortical Thickness Measured by T1 Magnetic Resonance Imaging
Time Frame: Baseline to immediately after the final rTMS treatment (5 weeks)
|
Percent change in medial prefrontal average cortical thickness
|
Baseline to immediately after the final rTMS treatment (5 weeks)
|
|
Fractional Anisotropy Measured by Diffusion Tensor Imaging
Time Frame: Baseline to immediately after the final rTMS treatment (5 weeks)
|
Percent change in medial prefrontal average fractional anisotropy
|
Baseline to immediately after the final rTMS treatment (5 weeks)
|
|
Functional Connectivity Measured by Functional Magnetic Resonance Imaging
Time Frame: Baseline to immediately after the final rTMS treatment (5 weeks)
|
Percent change in medial prefrontal average functional connectivity
|
Baseline to immediately after the final rTMS treatment (5 weeks)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Marc J Dubin, MD, PhD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1101011475
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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