Imaging Biomarkers for TMS Treatment of Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Device: repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT01900314
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-16
• Study Start: 2013-09
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Results First Submitted: 2017-01-09
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Results First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS	repetitive Transcranial Magnetic Stimulation (rTMS)	20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.
Sham rTMS	repetitive Transcranial Magnetic Stimulation (rTMS)	20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms at 4 Weeks	4 weeks after baseline	MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression

Secondary Outcome Measures

Name	Time	Method
Depression Symptoms at 4 Weeks- Secondary	4 weeks after baseline	Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe \> 22

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States