Major DepressionPhase 2NCT00577070
Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression
A Phase 2 study testing TMS in people with Major Depression, run by BeerYaakov Mental Health Center at 1 site in Israel.
Trial summary
There is a general consensus of efficacy of TMS in treatment of major depression,yet results are not satisfying.A new coil ("H"-coil, recently invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) is supposed to be capable of stimulating deeper brain structures than conventional… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Oct 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right handed ,18-65 year old male or female subjects
- Diagnosed according to DSM-V-TR as suffering from Major depression using SCID interview
- Score of 22 or more in the Hamilton Depression Rating Scale (HAM-D24)
- The present depressive episode have been treated with at least 2 different anti-depressive drugs at peak doses for at least 6 weeks with not more than a partial response.Augmentation strategies may be included.
Who cannot join
- Cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma patients suffering from chronic medical conditions of any sort:
- History of current hypertension
- History of seizure or heat convulsion
- History of epilepsy or seizure in first degree relatives
- History of head injury
- History of any metal in the head (outside the mouth)
Show all 18Show fewer
- Known history of any metallic particles in the eye
- Implanted cardiac pacemaker or any intra-cardiac lines
- Implanted neuro-stimulators
- Surgical clips or any medical pumps
- History of frequent or severe headaches
- History of migraine
- History of hearing loss
- Known history of cochlear implants
- History of drug abuse or alcoholism
- Pregnancy or not using a reliable method of birth control (non-pregnancy will be proved by beta-HCG test)
- Systemic and metabolic disorders
- Inadequate communication skills or under custodial care.
Trial locations and contacts
1 site in 1 country.
About this study
There is a general consensus of efficacy of TMS in treatment of major depression,yet results are not satisfying.A new coil ("H"-coil, recently invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) is supposed to be capable of stimulating deeper brain structures than conventional coils.TMS using this coil was named by its developers as "deep TMS" and will hence be refered to by this name.
So far, deep TMS have studied in Israel with promising sucssess in patients with Major depression (An on-going study).A safety study with good results have been recently published.The aim of this study is to reinforce initial results in major depression using deep TMS.
Read the detailed description
A group of 40 patients with major depression will be randomly assigned to deep TMS with H-1 coil in frequency of 20 HZ or H-2 coil in frequency of 0.1 HZ with 120% of motor threshold to the prefrontal cortex . No change in anti-depressant medication one month prior to study is a prerequisite.Deep TMS will be administered for 4 weeks.During TMS exposure subjects will be exposed to a conversation in which they talk about their depression and their ruminations.Patients will be evaluated using Hamilton Depression Rating Scale (HAM-D24),Hamilton Anxiety Rating Scale (HAM-A),Clinical Global Impression - Improvement(CGI-I) ,Beck Depression Inventory (BDI),Visual Analog Scale (VAS).
- Conditions
- Major Depression
- Being tested
- TMS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Transcranial Magnetic Stimulation (TMS) is a new tool in neuropsychiatry. This method is based on creating pre determined magnetic fields, which alternate rapidly. The magnetic fields are intended to cause electric induction in the brain cells and, as a consequence, generation of action potentials. The magnetic stimulation is delivered/ generated by a coil, positioned on the patient's scalp, inducing nerve stimulation within the brain. Therefore, when placed over the motor cortex, the magnetic stimulation creates Muscular Evoked potential, which can be measured by EMG.
| Study group | Role | What they receive |
|---|---|---|
| H1 | Active comparator | Includs 20 patients.These patients will be given 4 weeks (5 days a week) of deep TMS,20 minutes each session, to the left prefrontal cortex using H1 coil, in frequency of 20 HZ, with intensity of 120 % of motor threshold. H1-coil is an extracorporeal device positioned on the patient's scalp, designed to stimulate deep prefrontal brain regions, preferentially in the left hemisphere. The effective part of the coil, which has contact with the patient's scalp, includes 14 strips of 7-12 cm length. These strips are oriented in an anterior-posterior axis.This coil stimulates neuronal fibers in anterior-posterior orientation.
During deep TMS exposure patients will listen to a clinical interview in which they describe the different expressions of their depression including their ruminations and depressive schemas. Receives: Device: TMS |
| H2 | Experimental | Includs 20 patients.These patients will be given 4 weeks (5 days a week) of deep TMS, 20 minutes each session, to the prefrontal cortex bilateraly using H2 coil, in frequency of 0.1 HZ, with intensity of 120 % of motor threshold. H2-coil is designed to stimulate deep prefrontal brain regions bilaterally (without any preferencefor either hemisphere). The effective part of the coil, which has contact with the patient's scalp, includes 10 strips of 14-22 cm length.These strips are oriented in a right-left direction (lateral-medial axis).This coil is destined to stimulate lateral-medial neuronal fibers. During deep TMS exposure patients will listen to a clinical interview in which they describe the different expressions of their depression including their ruminations and depressive schemas. Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response defined as at least a 50% decrease in Hamilton Depression Rating Scale (HAM-D24). Remission is defined as below 8 in Hamilton Depression Rating Scale (HAM-D24)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeerYaakov Mental Health Center
- Sponsor type
- Other government
- Investigators
- Oded Rosenberg, M.D., Principal investigator, Beer Yaakov Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577070
- Sponsor's protocol ID
- TMS-204CTIL
- Status last verified
- Jan 2009
- First submitted
- 18 Dec 2007
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. 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- Augmentation for Drug Resistant Depression
- ClinicalTrials.gov ID
- NCT00577070
- Acronym / sponsor ID
- TMS-204CTIL
- Conditions
- Major Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BeerYaakov Mental Health CenterOther government
- Study start
- Jan 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Dec 2007 (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.
There is a general consensus of efficacy of TMS in treatment of major depression,yet results are not satisfying.A new coil ("H"-coil, recently invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) is supposed to be capable of stimulating deeper brain structures than conventional coils.TMS using this coil was named by its developers as "deep TMS" and will hence be refered to by this name.
So far, deep TMS have studied in Israel with promising sucssess in patients with Major depression (An on-going study).A safety study with good results have been recently published.The aim of this study is to reinforce initial results in major depression using deep TMS.
Detailed description
A group of 40 patients with major depression will be randomly assigned to deep TMS with H-1 coil in frequency of 20 HZ or H-2 coil in frequency of 0.1 HZ with 120% of motor threshold to the prefrontal cortex . No change in anti-depressant medication one month prior to study is a prerequisite.Deep TMS will be administered for 4 weeks.During TMS exposure subjects will be exposed to a conversation in which they talk about their depression and their ruminations.Patients will be evaluated using Hamilton Depression Rating Scale (HAM-D24),Hamilton Anxiety Rating Scale (HAM-A),Clinical Global Impression - Improvement(CGI-I) ,Beck Depression Inventory (BDI),Visual Analog Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H1 | Active comparator | Device: TMSIncluds 20 patients.These patients will be given 4 weeks (5 days a week) of deep TMS,20 minutes each session, to the left prefrontal cortex using H1 coil, in frequency of 20 HZ, with intensity of 120 % of motor threshold. H1-coil is an extracorporeal device positioned on the patient's scalp, designed to stimulate deep prefrontal brain regions, preferentially in the left hemisphere. The effective part of the coil, which has contact with the patient's scalp, includes 14 strips of 7-12 cm length. These strips are oriented in an anterior-posterior axis.This coil stimulates neuronal fibers in anterior-posterior orientation. During deep TMS exposure patients will listen to a clinical interview in which they describe the different expressions of their depression including their ruminations and depressive schemas. |
| H2 | Experimental | Device: TMSIncluds 20 patients.These patients will be given 4 weeks (5 days a week) of deep TMS, 20 minutes each session, to the prefrontal cortex bilateraly using H2 coil, in frequency of 0.1 HZ, with intensity of 120 % of motor threshold. H2-coil is designed to stimulate deep prefrontal brain regions bilaterally (without any preferencefor either hemisphere). The effective part of the coil, which has contact with the patient's scalp, includes 10 strips of 14-22 cm length.These strips are oriented in a right-left direction (lateral-medial axis).This coil is destined to stimulate lateral-medial neuronal fibers. During deep TMS exposure patients will listen to a clinical interview in which they describe the different expressions of their depression including their ruminations and depressive schemas. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Right handed ,18-65 year old male or female subjects
- Diagnosed according to DSM-V-TR as suffering from Major depression using SCID interview
- Score of 22 or more in the Hamilton Depression Rating Scale (HAM-D24)
- The present depressive episode have been treated with at least 2 different anti-depressive drugs at peak doses for at least 6 weeks with not more than a partial response.Augmentation strategies may be included.
Key exclusion criteria (18 listed)
- Cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma patients suffering from chronic medical conditions of any sort:
- History of current hypertension
- History of seizure or heat convulsion
- History of epilepsy or seizure in first degree relatives
- History of head injury
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 |
|---|---|---|
| TMSTranscranial Magnetic Stimulation (TMS) is a new tool in neuropsychiatry. This method is based on creating pre determined magnetic fields, which alternate rapidly. The magnetic fields are intended to cause electric induction in the brain cells and, as a consequence, generation of action potentials. The magnetic stimulation is delivered/ generated by a coil, positioned on the patient's scalp, inducing nerve stimulation within the brain. Therefore, when placed over the motor cortex, the magnetic stimulation creates Muscular Evoked potential, which can be measured by EMG. | Device | H1, H2 |
Primary outcome
Treatment response defined as at least a 50% decrease in Hamilton Depression Rating Scale (HAM-D24). Remission is defined as below 8 in Hamilton Depression Rating Scale (HAM-D24)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
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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.
Oded Rosenberg, M.D. principal investigator
Beer Yaakov Mental Health Center
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 TMS in people with Major Depression, run by BeerYaakov 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 4 inclusion and 18 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: finished, as of the sponsor's last update on 6 Oct 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response defined as at least a 50% decrease in Hamilton Depression Rating Scale (HAM-D24). Remission is defined as below 8 in Hamilton Depression Rating Scale (HAM-D24) (time frame: 2 months). 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 6 Oct 2009.