N/A
N=28
Antidepressant Mechanisms of Transcranial Magnetic Stimulation
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02466230 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Depression Severity Measured by the Hamilton Depression Rating Scale (24-Item) — 18.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Repetitive transcranial magnetic stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Severity Measured by the Hamilton Depression Rating Scale (24-Item) |
18.2 | — |
| SECONDARY Depression Severity Measured by the Public Health Questionnaire-9 |
9.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02466230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.