Patients With Resistant Depressive DisordersPhase 2rTMSNCT03656900
Monocentric Pilot Study, for a Randomized, Crossover, Blinded Trial: Comparison of the Therapeutic Efficacy of Low Frequency Repeated Transcranial Magnetic Stimulation on Cortical Area 9 Compared to Brodmann Area 46 in the Treatment of Depressive Disorders.
A Phase 2 study testing rTMS BA9/BA46, rTMS BA46/BA9 and brain MRI in people with Patients With Resistant Depressive Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) is a new therapeutic tool used in psychiatry. Non-invasive, well tolerated and requiring no premedication, it is performed on an outpatient basis. The principle of this technique is to stimulate the cerebral cortex from an electromagnetic coil placed on the scalp. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients With Resistant Depressive Disorders
- What is being tested?
- rTMS BA9/BA46, rTMS BA46/BA9 and brain MRI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with resistant depressive disorders (Hamilton-17-item scale > 22, failure ≥ 2 antidepressants) with at least one of the following criteria :
- venlafaxine treatment failure (unlike the national PHRC, patients who receive/have received venlafaxine treatment for the current depressive episode are included),
- therapeutic failure in PHRC national rTMS 2007,
- refusal to participate in the PHRC national rTMS 2007.
Who cannot join
- Bipolar disorders: type I or II,
- Depression with psychotic characteristics,
- Schizophrenia,
- Risky or harmful use of alcohol and/or an illicit psychoactive substance,
- Dependence on alcohol and/or an illicit psychoactive substance,
- Sick and hospitalized under duress or under legal protection (guardianship, curatorship),
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- Contraindication to the practice of rTMS; personal history of seizures, history of neurological or neurosurgical pathologies, metallic prosthetic materials or foreign bodies (pacemaker, etc...),
- Contraindication to brain MRI,
- Pregnancy or breastfeeding in progress
- Resistance to Escitalopram
Trial locations and contacts
1 site in 1 country.
About this study
Repetitive transcranial magnetic stimulation (rTMS) is a new therapeutic tool used in psychiatry. Non-invasive, well tolerated and requiring no premedication, it is performed on an outpatient basis. The principle of this technique is to stimulate the cerebral cortex from an electromagnetic coil placed on the scalp. Unlike electroconvulsive therapy, rTMS induces an electrical current on a well-defined region of the cerebral cortex.
In psychiatry, this technique is mainly considered in the treatment of depressive disorders resistant to antidepressant medication. The brain target, obtained from brain imaging data in depressed patients, is the dorsolateral prefrontal cortex (DLPFC). The Food and Drug Administration (FDA) has recognized the interest of rTMS for treating depressive disorders (October 7, 2008).
However, some stimulation parameters still need to be optimized before rTMS can be considered a therapeutic method in its own right and used routinely. Indeed, its effectiveness over time has not yet been evaluated, and rTMS has shown a lack of reproducibility between subjects [Foucher, 2007]. Finally, the therapeutic results of rTMS are very modest whatever the study [Daskalakis, 2008]. Additional studies are therefore needed to optimize stimulation parameters.
- Being tested
- rTMS BA9/BA46, rTMS BA46/BA9, brain MRI, Medical evaluation, Psychological assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS BA9/BA46Device
10 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 9, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 46.
rTMS BA46/BA9Device
10 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 46, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 9.
brain MRIRadiation
T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.
Medical evaluationOther
complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU)
Psychological assessmentOther
Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment
| Study group | Role | What they receive |
|---|---|---|
| BA9/BA46 | Experimental | Not described Receives: Device: rTMS BA9/BA46; Radiation: brain MRI; Other: Medical evaluation; Other: Psychological assessment |
| BA46/BA9 | Experimental | Not described Receives: Device: rTMS BA46/BA9; Radiation: brain MRI; Other: Medical evaluation; Other: Psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The remission rate
Compare the remission rates (decrease < 50% of the HDRS score / initial score) during neuronavigated stimulations on BA 9 and BA 46 compared to the average rate obtained during manual stimulation.
Measured: Through study completion, an average of 11 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Resistant Depressive DisordersStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656900
- Sponsor's protocol ID
- TROJAK 2009
- Acronym
- rTMS
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Pilot Study, for a Randomized, Crossover, Blinded Trial: Comparison of the Therapeutic Efficacy of Low Frequency Repeated Transcranial Magnetic Stimulation on Cortical Area 9 Compared to Brodmann Area 46 in the Treatment of Depressive Disorders.
- ClinicalTrials.gov ID
- NCT03656900
- Acronym / sponsor ID
- rTMS / TROJAK 2009
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Sep 2018 (actual)
- 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.
Repetitive transcranial magnetic stimulation (rTMS) is a new therapeutic tool used in psychiatry. Non-invasive, well tolerated and requiring no premedication, it is performed on an outpatient basis. The principle of this technique is to stimulate the cerebral cortex from an electromagnetic coil placed on the scalp. Unlike electroconvulsive therapy, rTMS induces an electrical current on a well-defined region of the cerebral cortex.
In psychiatry, this technique is mainly considered in the treatment of depressive disorders resistant to antidepressant medication. The brain target, obtained from brain imaging data in depressed patients, is the dorsolateral prefrontal cortex (DLPFC). The Food and Drug Administration (FDA) has recognized the interest of rTMS for treating depressive disorders (October 7, 2008).
However, some stimulation parameters still need to be optimized before rTMS can be considered a therapeutic method in its own right and used routinely. Indeed, its effectiveness over time has not yet been evaluated, and rTMS has shown a lack of reproducibility between subjects [Foucher, 2007]. Finally, the therapeutic results of rTMS are very modest whatever the study [Daskalakis, 2008]. Additional studies are therefore needed to optimize stimulation parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BA9/BA46 | Experimental | Device: rTMS BA9/BA46, Radiation: brain MRI, Other: Medical evaluation, Other: Psychological assessment |
| BA46/BA9 | Experimental | Device: rTMS BA46/BA9, Radiation: brain MRI, Other: Medical evaluation, Other: Psychological assessment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with resistant depressive disorders (Hamilton-17-item scale > 22, failure ≥ 2 antidepressants) with at least one of the following criteria :
- venlafaxine treatment failure (unlike the national PHRC, patients who receive/have received venlafaxine treatment for the current depressive episode are included),
- therapeutic failure in PHRC national rTMS 2007,
- refusal to participate in the PHRC national rTMS 2007.
Key exclusion criteria (10 listed)
- Bipolar disorders: type I or II,
- Depression with psychotic characteristics,
- Schizophrenia,
- Risky or harmful use of alcohol and/or an illicit psychoactive substance,
- Dependence on alcohol and/or an illicit psychoactive substance,
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 |
|---|---|---|
| rTMS BA9/BA4610 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 9, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 46. | Device | BA9/BA46 |
| rTMS BA46/BA910 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 46, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 9. | Device | BA46/BA9 |
| brain MRIT1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation. | Radiation | BA46/BA9, BA9/BA46 |
| Medical evaluationcomplete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU) | Other | BA46/BA9, BA9/BA46 |
| Psychological assessmentSubjective Life Profile Assessment (SLPA) and Helping Alliance Assessment | Other | BA46/BA9, BA9/BA46 |
Primary outcome
The remission rate
Time frame: Through study completion, an average of 11 weeks.
Compare the remission rates (decrease < 50% of the HDRS score / initial score) during neuronavigated stimulations on BA 9 and BA 46 compared to the average rate obtained during manual stimulation.
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 4 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 rTMS BA9/BA46, rTMS BA46/BA9 and brain MRI in people with Patients With Resistant Depressive Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 10 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 4 Sep 2018. 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 France. 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?
The remission rate (time frame: Through study completion, an average of 11 weeks.). 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 4 Sep 2018.