- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01900314
Imaging Biomarkers for TMS Treatment of Depression
April 20, 2017 updated by: Stephan Taylor, University of Michigan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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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:
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive Symptoms at 4 Weeks
Time Frame: 4 weeks after baseline
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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
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4 weeks after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression Symptoms at 4 Weeks- Secondary
Time Frame: 4 weeks after baseline
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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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4 weeks after baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephan F Taylor, MD, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
July 11, 2013
First Submitted That Met QC Criteria
July 15, 2013
First Posted (Estimate)
July 16, 2013
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 20, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00053677
- 1R21MH098174-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
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University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
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University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
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Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
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Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on repetitive Transcranial Magnetic Stimulation (rTMS)
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Centre Hospitalier Universitaire de NiceCompletedPost-traumatic Stress DisorderFrance
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MGH Institute of Health ProfessionsNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
Kaohsiung Veterans General Hospital.RecruitingBipolar II Disorder, Most Recent Episode Major DepressiveTaiwan
-
Centre hospitalier de Ville-Evrard, FranceRecruiting
-
Krystal Parker, PhDRecruitingDepression | Schizophrenia | Parkinson Disease | Bipolar Disorder | Autism Spectrum DisorderUnited States
-
Brigham and Women's HospitalBeth Israel Deaconess Medical Center; Mclean HospitalNot yet recruitingObesity | Appetitive BehaviorUnited States
-
Yi YangNot yet recruiting
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Mclean HospitalNational Institute of Mental Health (NIMH); Beth Israel Deaconess Medical CenterRecruitingSchizophrenia | Schizo Affective DisorderUnited States
-
Tehran University of Medical SciencesUnknownBorderline Personality Disorder