Status:
TERMINATED
Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring
Lead Sponsor:
Boston University
Collaborating Sponsors:
Boston Medical Center
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
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 Depressio...
Detailed Description
Transcranial magnetic stimulation (TMS) has demonstrated efficacy as a treatment for major depression. No objective markers have been identified that indicate which patients are most likely to respond...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01192685
Start Date
December 1 2012
End Date
December 1 2013
Last Update
April 20 2017
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118