Antidepressant Mechanisms of Transcranial Magnetic Stimulation

NCT02466230 | Completed Results FDA Device

• 1 other identifier: 1101011475
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study utilizes resting state fMRI, arterial spin labelling imaging, diffusion tensor imaging, structural MR-imaging, and MR-spectroscopy of GABA and Glutamate to probe the antidepressant mechanisms of repetitive transcranial magnetic stimulation (rTMS). The above imaging modalities will be acquired before and after an open-label 5 week course of rTMS for depression in currently depressed individuals with treatment resistant depression. Changes in functional, structural, and neurochemical markers will be investigated in rTMS responders and nonresponders to elucidate mechanisms of plasticity that correlate with treatment response. Additionally, functional, structural, and neurochemical signatures at baseline that correlate with subsequent treatment response will be investigated.

Conditions

Depression

Keywords

Magnetic stimulation of the brain; Antidepressant mechanisms

Outcome Measures

Primary Outcomes (1)

• Depression Severity Measured by the Hamilton Depression Rating Scale (24-Item)

  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 Outcomes (1)

• Depression Severity Measured by the Public Health Questionnaire-9

  Change in score in Public Health Questionnaire-9 from baseline to immediately after the final rTMS treatment (5 weeks)

Other Outcomes (5)

• Gamma-amino-butyric Acid Level Measured by Magnetic Resonance Spectroscopy

  Baseline to immediately after the final rTMS treatment (5 weeks)

• Glutamate Level Measured by Magnetic Resonance Spectroscopy

  Baseline to immediately after the final rTMS treatment (5 weeks)

• Cortical Thickness Measured by T1 Magnetic Resonance Imaging

  Baseline to immediately after the final rTMS treatment (5 weeks)

Study Arms (1)

Active rTMS

EXPERIMENTAL

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.

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

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.

Active rTMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator
• Neuronetics: collaborator

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Marc Dubin, M.D.
• Organization: Weill Cornell Medical College

mrd9035@med.cornell.edu

(212) 746-5817

Study Officials

• Marc J Dubin, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 9, 2015
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 10, 2018
• Results First Posted: September 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share