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Trial record 22 of 2701 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Imaging Biomarkers for TMS Treatment of Depression

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ClinicalTrials.gov Identifier: NCT01900314
Recruitment Status : Completed
First Posted : July 16, 2013
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Neuronetics
Information provided by (Responsible Party):
Stephan Taylor, 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.

Condition or disease Intervention/treatment Phase
Depression Device: repetitive Transcranial Magnetic Stimulation (rTMS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Imaging Biomarkers for TMS Treatment of Depression
Study Start Date : September 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active 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.
Device: 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 sham arm.
Other Names:
  • TMS
  • NeuroStar
  • Sham treatment

Sham Comparator: Sham 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.
Device: 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 sham arm.
Other Names:
  • TMS
  • NeuroStar
  • Sham treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900314


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Neuronetics
Investigators
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Principal Investigator: Stephan F Taylor, MD University of Michigan

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephan Taylor, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT01900314     History of Changes
Other Study ID Numbers: HUM00053677
1R21MH098174-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2013    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Stephan Taylor, University of Michigan:
Major Depression
Major Depressive Disorder
TMS
rTMS

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders