Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring
Depression
About this trial
This is an interventional device feasibility trial for Depression focused on measuring Depression, Depressed, TMS, Transcranial Magnetic Stimulation
Eligibility Criteria
Inclusion criteria List
- Depressive disorder Diagnostic Statistical Manual of Mental Disorders, fourth Edition, Text Revision (DSM-IV-TR).
- MADRAS score of 26 or above and history of depression, as defined by meeting DSM-IV criteria for major depression, dysthymic disorder, or substance-induced mood disorder.
- Male or female aged 18 to 65.
- Females who are not pregnant or nursing.
- Individuals able to provide informed written consent and are able to comply with study procedures.
- Subjects who have received or are receiving anti-depressant medication.
- Patients who are depressed as assessed by the above criteria and have not had optimum response to their antidepressant medication in their current episode.
Exclusion criteria List
- Any Axis I diagnosis that, in the opinion of the investigators, may interfere with the course of the trial.
- Any current diagnoses of alcohol abuse or dependence.
- Any current substance use disorder.
- Medical or neurological illness that in the investigators judgment would make study compliance difficult or would be a contraindication for use with TMS.
- Currently receiving any medication that markedly increases the risks for seizures, for example: tricyclic antidepressants, INH, meperidine, lidocaine, and clozapine.
- Subjects who have implanted metallic devices or non-removable metallic objects in or around the head that can be magnetized, however metal fillings, braces, and dental implants are acceptable.
- Subjects who have implanted devices that emit physiological signals including cardioverter defibrillators (ICDs), and vagus nerve stimulators.
- Subjects who have received any investigational drug during the prior 30 days.
- Clinically significant abnormal lab values as assesses by the Investigator.
- Risk for suicidal behavior based on clinician assessment and a score of greater than 5 on the suicidal thought item of the MADRS or a score of 4 on the suicide item of the Hamilton Depression rating scale.
- Subjects who have had a serious suicide attempt in the past year as assessed by the Investigator.
- Current other somatic antidepressant therapy, i.e. vagus nerve stimulation, electroconvulsive therapy, or phototherapy.
- Started psychotherapy in the past 30 days.
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Other
Depressed outpatients treated with TMS
This a 12- week study (1-4 week screening, 6 weeks treatment, 2 weeks follow-up) outpatient open label clinical trial. Twenty-five subjects diagnosed with depression with a Montgomery Asberg Depression Rating Scale (MADRAS) score of 26 or higher, will be enrolled into this trial, up to fifty subjects will be consented. Transcranial Magnetic Stimulation (TMS) will be administered to subjects 5 days a week for 6 weeks. Near infrared spectroscopy (NIRS), a spectroscopic method that uses the near infrared region of the electromagnetic spectrum (from about 700 nm to 2500 nm), will be used to assess blood flow in the brain.