Depression
Conditions
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-patients, 68 years of age and above, currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be conducted before starting the trial (screening), once a week for the trial duration and one month following end of treatment.
Interventions
DEVICEdTMS treatment (H1 Coil)
All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.
Sponsors
Shalvata Mental Health Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
68 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the H1-Coil | One Month | maintaining subject's pre treatment, physical and neurological status. |
| Clinical antidepressant response | One Month | a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical antidepressant remission | One Month | exit Hamilton Depression Rating Scale \<9. |
| Symptomatic improvement at the end point. | One Month | Change in Hamilton Anxiety Rating Scale (HARS), Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR), Clinical Global Impression (CGI). |
Countries
Israel
Contacts
Primary ContactDafna Shefet, MD
Outcome results
None listed