Imaging Biomarkers for TMS Treatment of Depression

Depression Clinical Trial

Official title:

Imaging Biomarkers for TMS Treatment of Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900314
• Other study ID #: HUM00053677
• Secondary ID: 1R21MH098174-01A
• Status: Completed
• Phase: N/A
• First received: July 11, 2013
• Last updated: April 20, 2017
• Start date: September 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH), Neuronetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptoms at 4 Weeks	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	4 weeks after baseline
Secondary	Depression Symptoms at 4 Weeks- Secondary	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	4 weeks after baseline

External Links

•   U of M Clinical Studies