Status:
UNKNOWN
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly
Lead Sponsor:
Shalvata Mental Health Center
Conditions:
Depression
Eligibility:
All Genders
68+ years
Phase:
PHASE2
Brief Summary
Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in elderly patients suffering from major depressive episode. Twenty-seven (27) treatment resistance depressed-pa...
Eligibility Criteria
Inclusion
- Diagnosed by a senior psychiatrist as suffering from major depression episode according to DSM-IV (either as a part of a unipolar or a bipolar disorder).
- Rating on HDRS ≥ 20.
- Age: 68 years and above
- Treated for the current depressive episode, at least 6 weeks per antidepressant with one antidepressant in accepted dose, without improvement, and/or intolerance to 2 antidepressants, according to medical chart and ATHF (antidepressant treatment history form) instruction guidelines.
- Gave informed consent for participation in the study.
- Negative answers on safety screening questionnaire for TMS.
- If referred by a treating psychiatrist, he or she approves of the subject's participation in the study.
Exclusion
- Axis 2 diagnosis, which is considered prominent to the current depressive episode.
- Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
- Attempted suicide in the past year.
- Cognitive impermanent - if MMSE \< 24, patient will be further assessed , and may be excluded according to the primary investigator's discretion
- History of seizure.
- History of epilepsy or seizure in first degree relatives.
- Any CNS disorder that may increase risk of seizure significantly
- History of a significant head injury.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- History of frequent or severe headaches.
- Use of hearing aids for hearing loss.
- Known history of cochlear implants.
- History of drug abuse or alcoholism.
- Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
- Inadequate communication with the patient.
- Under custodial care.
- Participation in current clinical study or clinical study within 30 days prior to this study.
- Patients suffering from bipolar disorder, not currently treated by mood stabilizers
- Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01521052
Start Date
January 1 2012
Last Update
January 30 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shalvata Mental Health Center
Hod HaSharon, Israel