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OpenTrials
Completed

NCT Number: NCT01900314

Imaging Biomarkers for TMS Treatment of Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

Other names: TMS, NeuroStar, Sham treatment

Primary outcomes

  1. Depressive Symptoms at 4 Weeks

    Time frame: 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 outcomes

  1. Depression Symptoms at 4 Weeks- Secondary

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Neuronetics

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 16, 2013
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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