Evaluation of the H-Coil Transcranial Magnetic Stimulatio... | NCT01521052

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
elderly depressed patients	Experimental	Twenty seven (27) patients aged 68 years or above, currently suffering from a major depressive episode, who did not respond to treatment with at least one antidepressant medications in the recommended dosage and duration, or could not tolerate at least two antidepressants.	Device: dTMS treatment (H1 Coil)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dTMS treatment (H1 Coil)	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of the H1-Coil	maintaining subject's pre treatment, physical and neurological status.	One Month
Clinical antidepressant response	a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.	One Month

Secondary Outcomes

Measure	Description	Time Frame
Clinical antidepressant remission	exit Hamilton Depression Rating Scale <9.	One Month
Symptomatic improvement at the end point.	Change in Hamilton Anxiety Rating Scale (HARS), Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR), Clinical Global Impression (CGI).

Eligibility Module

Eligibility Criteria

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.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior