Major DepressionPhase 1/2NCT00460902
Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication
A Phase 1/2 study testing Transcranial Magnetic Stimulation (TMS) in people with Major Depression, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesIsrael
- Study dates
- Apr 2007to Aug 2009
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as suffering from treatment resistant major depression
- Right laterality
Who cannot join
- other major axis I diagnosis
- severe axis II diagnosis
- risk factors to convulsions
- history of drug abuse in the past year
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Beer Yaacov Medical Center
Beer Yaacov
Biological psychiatry unit, Psychiatric ward, Hadassah Medical organization
Jerusalem
About this study
Official title: Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression
Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation.
- Conditions
- Major Depression
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- TMS, drug resistant depression
- 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.
Transcranial Magnetic Stimulation (TMS)Device
| Study group | Role | What they receive |
|---|---|---|
| Deep TMS stimulation | Experimental | Not described Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| DTMS with positive cognitive-emotional provocation | Experimental | Not described Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| DTMS with negative cognitive-emotional provocation | Experimental | Not described Receives: Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMILTON RATING SCALE FOR DEPRESSION 24 items
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshe Isserles, Hadassah Medical Organization
- Investigators
- Moshe Isserles, MD, MSc, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460902
- Sponsor's protocol ID
- 395/3.11.06(HMO)
- Status last verified
- Mar 2015
- First submitted
- 15 Apr 2007
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Isserles M, Rosenberg O, Dannon P, Levkovitz Y, Kotler M, Deutsch F, Lerer B, Zangen A. Cognitive-emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcome. J Affect Disord. 2011 Feb;128(3):235-42. doi: 10.1016/j.jad.2010.06.038. Epub 2010 Jul 21.
PubMed 20663568
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. 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
- NCT00460902
- Acronym / sponsor ID
- 395/3.11.06(HMO)
- Conditions
- Major Depression
- Keywords
- TMS, drug resistant depression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Apr 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.
Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deep TMS stimulation | Experimental | Device: Transcranial Magnetic Stimulation (TMS) |
| DTMS with positive cognitive-emotional provocation | Experimental | Device: Transcranial Magnetic Stimulation (TMS) |
| DTMS with negative cognitive-emotional provocation | Experimental | Device: Transcranial Magnetic Stimulation (TMS) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed as suffering from treatment resistant major depression
- Right laterality
Key exclusion criteria (4 listed)
- other major axis I diagnosis
- severe axis II diagnosis
- risk factors to convulsions
- history of drug abuse in the past year
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Device | DTMS with negative cognitive-emotional provocation, DTMS with positive cognitive-emotional provocation, Deep TMS stimulation |
Primary outcome
HAMILTON RATING SCALE FOR DEPRESSION 24 items
Time frame: 4 weeks
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 20 Mar 2015.
- Background: PubMed 20663568Isserles M, Rosenberg O, Dannon P, Levkovitz Y, Kotler M, Deutsch F, Lerer B, Zangen A. Cognitive-emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcome. J Affect Disord. 2011 Feb;128(3):235-42. doi: 10.1016/j.jad.2010.06.038. Epub 2010 Jul 21.
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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.
Moshe Isserles, MD, MSc principal investigator
Hadassah Medical Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial Magnetic Stimulation (TMS) in people with Major Depression, run by Hadassah Medical Organization at 2 sites 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 2 inclusion and 4 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 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
HAMILTON RATING SCALE FOR DEPRESSION 24 items (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460902, which also lists 1 linked publication.
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 20 Mar 2015.