N/A
N=40
Imaging Biomarkers for TMS Treatment of Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT01900314 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Depressive Symptoms at 4 Weeks — 15.6; 15.6 units on a scale — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptoms at 4 Weeks |
15.6; 15.6 | 0.16 |
| SECONDARY Depression Symptoms at 4 Weeks- Secondary |
9.1; 10.1 | 0.04 sig |
Summary
The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.
Eligibility Criteria
Inclusion Criteria
- Primary diagnosis of major depressive disorder
- Male and female subjects, ages 22-65
- Have failed at least 1 antidepressant medication at adequate dose and duration
- On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy
Exclusion Criteria
- Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
- Active substance abuse, including alcohol
- Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
- No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
- Pregnant or trying to get pregnant
- Failed to respond to an adequate course of electroconvulsive therapy (ECT)
- Previous treatment with TMS
- Current depressive episode longer than 5 years
Data sourced from ClinicalTrials.gov (NCT01900314). 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.