DepressionPhase 2NCT01521052
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly
A Phase 2 study testing dTMS treatment (H1 Coil) in people with Depression, run by Shalvata Mental Health Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 68 years and older
- Conditions the study is for
- Depression
- What is being tested?
- dTMS treatment (H1 Coil)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 68 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shalvata Mental Health Center
Hod HaSharon
Dafna Shefet, MD, 972-9-7478524, daphnash@clalit.org.il
Dafna Shefet, MD
About this study
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.
- Conditions
- Depression
- Being tested
- dTMS treatment (H1 Coil)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: dTMS treatment (H1 Coil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the H1-Coil
maintaining subject's pre treatment, physical and neurological status.
Measured: One Month
Clinical antidepressant response
a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.
Measured: One Month
Secondary outcomes (2)
Clinical antidepressant remission
exit Hamilton Depression Rating Scale <9.
Measured: 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).
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521052
- Sponsor's protocol ID
- SHA-0001-11
- Status last verified
- Jan 2012
- First submitted
- 25 Jan 2012
- Last updated
- 30 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly
- ClinicalTrials.gov ID
- NCT01521052
- Acronym / sponsor ID
- SHA-0001-11
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly depressed patients | Experimental | Device: dTMS treatment (H1 Coil)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. |
Who may qualify
- Ages
- 68 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dTMS 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. | Device | elderly depressed patients |
Primary outcome
Safety of the H1-Coil
Time frame: One Month
maintaining subject's pre treatment, physical and neurological status.
Clinical antidepressant response
Time frame: One Month
a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.
2 secondary outcomes
Clinical antidepressant remission
Time frame: One Month
Symptomatic improvement at the end point.
Time frame: One Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dTMS treatment (H1 Coil) in people with Depression, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dafna Shefet, MD (972-9-7478524, daphnash@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the H1-Coil (time frame: One Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2012.