Status:
TERMINATED
Repetitive Transcranial Magnetic Stimulation for Treating Depression: A Functional Magnetic Resonance Imaging Study
Lead Sponsor:
Washington University School of Medicine
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This protocol, "Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder (MDD): A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study," is an ope...
Detailed Description
Depression is accompanied by rumination that supports inwardly focused cognitive attention on negative events and emotions. There is evidence to indicate that one aspect of this ruminative behavior li...
Eligibility Criteria
Inclusion
- SCREENING/DIAGNOSTIC REQUIREMENTS:
- Male or female outpatients, ages 18-50 (some literature has shown increasing cortical distance with age that may affect treatment outcome
- Hamilton Rating Scale of Depression (HRSD-24) \> 18
- New onset major depression or untreated recurrent major depression per DSM-IV-TR38 criteria.
- Not taking antidepressant medication or any other psychotropic medication
- Using an adequate contraceptive method
- Able to give informed consent
- Available for 4 weeks of daily therapy, working hours, Mon.-Fri.
- English-speaking
Exclusion
- DIAGNOSTIC EXCLUSIONS:
- Co-morbid psychiatric diagnosis of bipolar disorder, acute OCD, schizophrenia or schizoaffective or concurrent treatment with outpatient ECT, or personality disorder or MDD with suicidal ideation as determined by history and/or by P.I. examination requiring hospital admission or referral for acute care.
- Previous failure to respond to treatment with rTMS
- Failure to achieve satisfactory improvement in depression after two or more adequate trials of antidepressant medications.
- MEDICAL EXCLUSIONS:
- Patients newly diagnosed with thyroid dysfunction
- History of drug and/or ETOH dependence
- History of seizures
- History of head injury with loss of consciousness \> 5 minutes
- Any implantable metal object in the skull or near their head
- Any implantable devices such as a cardiac pacemaker, vagal nerve stimulator, etc.
- Positive urine pregnancy test
- Severe migraine headaches uncontrolled with routine non-narcotic medication
- Any medical condition in the opinion of the Investigator that might confound the results of the study Contraindications to fcMRI procedure
- Intake of NSAIDS, narcotic or muscle relaxants within 72 hours of the fMRI protocol.
- Claustrophobia.
- Left-handedness (may influence cerebral cortical hemispheric dominance).
- Inability to tolerate, or medical contraindication to MRI testing (e.g. metal prostheses or implants, history of claustrophobia)
- PROTOCOL SPECIFIC EXCLUSIONS:
- Unable to determine motor threshold for determining treatment dose with rTMS device
- Mini Mental Status Exam (MMSE)70 score \< 24.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01162382
Start Date
January 1 2010
End Date
September 1 2013
Last Update
February 18 2019
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110