Pharmacoresistant DepressionNCT02559466
Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Clinical Study Coupled With Positon Emission Tomography (PET)
A study testing Transcranial Magnetic Stimulation (TMS - ) - MagPro® and Positon Emission Tomography (PET) - Discovery 710® in people with Pharmacoresistant Depression, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS efficiency remains however unknown; besides local effect on the target, TMS may induce interaction changes between remote cerebral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacoresistant Depression
- What is being tested?
- Transcranial Magnetic Stimulation (TMS - ) - MagPro® and Positon Emission Tomography (PET) - Discovery 710®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2015to 23 May 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who met the diagnosis of major depressive episode (MDE)
- Patient right-handed
- Men and women aged over 18 years with major depressive episode IV (DSM-IV criteria), isolated or recurrent.
- Scores on the scale MADRS> 20
- Resistance Criterion defined as the failure of two antidepressants effective dose for a minimum of six weeks.
- Drug Therapy stable for at least 2 weeks
Who cannot join
- Bipolar disorder type I or type II
- Depression With Psychotic Features
- Diagnosis according comorbid Axis I (DSM IV) with schizophrenia, alcohol abuse and / or toxic substances.
- Inpatient under stress or under legal protection measure (guardianship, curatorship)
- Counter to the practice of Transcranial Magnetic Stimulation : a personal history of seizure, history of neurological or neurosurgical pathologies, metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.).
- Pregnant or breastfeeding ongoing.
- Somatic disorder may affect cognitive abilities and brain structures
- Known allergy to any component of Fludeoxyglucose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Randomized Clinical Study Coupled With Positon Emission Tomography (PET)
Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS efficiency remains however unknown; besides local effect on the target, TMS may induce interaction changes between remote cerebral regions. On the other hand, few studies have been performed in comparison to sham placebo stimulation. The investigators recently showed that non-responder depressive patients to TMS exhibited deeper and wider brain functional abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device capable of inducing a magnetic field with a deeper and wider distribution than standard coils.
The investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography (PET). The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach for the patient.
- Conditions
- Pharmacoresistant Depression
- Being tested
- Transcranial Magnetic Stimulation (TMS - ) - MagPro®, Positon Emission Tomography (PET) - Discovery 710®
- Keywords
- pharmaco-resistant depressed patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS - ) - MagPro®Device
Class IIa
Positon Emission Tomography (PET) - Discovery 710®Device
Class IB
| Study group | Role | What they receive |
|---|---|---|
| Patients stimulated with a H-TMS (deep) | Experimental | 20 sessions navigated with Deep Transcranial Magnetic Stimulation Receives: Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®; Device: Positon Emission Tomography (PET) - Discovery 710® |
| Patients stimulated with a conventional TMS | Other | 20 sessions navigated with Conventional Transcranial Magnetic Stimulation Receives: Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®; Device: Positon Emission Tomography (PET) - Discovery 710® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).
performed before and after TMS
Measured: 24 month
Secondary outcomes (1)
Short self-completion questionnaire on symptoms of depression
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start17 Jul 2015
- Primary completion18 Apr 2018
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacoresistant DepressionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559466
- Sponsor's protocol ID
- 2015-08
- Other IDs
- RCAPHM15_0084, 2015-A00345-44
- Status last verified
- May 2023
- First submitted
- 23 Sep 2015
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Randomized Clinical Study Coupled With Positon Emission Tomography (PET)
- ClinicalTrials.gov ID
- NCT02559466
- Acronym / sponsor ID
- 2015-08
- Conditions
- Pharmacoresistant Depression
- Keywords
- pharmaco-resistant depressed patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 17 Jul 2015 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 24 Sep 2015 (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.
Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS efficiency remains however unknown; besides local effect on the target, TMS may induce interaction changes between remote cerebral regions. On the other hand, few studies have been performed in comparison to sham placebo stimulation. The investigators recently showed that non-responder depressive patients to TMS exhibited deeper and wider brain functional abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device capable of inducing a magnetic field with a deeper and wider distribution than standard coils.
The investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography (PET). The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients stimulated with a H-TMS (deep) | Experimental | Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®, Device: Positon Emission Tomography (PET) - Discovery 710®20 sessions navigated with Deep Transcranial Magnetic Stimulation |
| Patients stimulated with a conventional TMS | Other | Device: Transcranial Magnetic Stimulation (TMS - ) - MagPro®, Device: Positon Emission Tomography (PET) - Discovery 710®20 sessions navigated with Conventional Transcranial Magnetic Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who met the diagnosis of major depressive episode (MDE)
- Patient right-handed
- Men and women aged over 18 years with major depressive episode IV (DSM-IV criteria), isolated or recurrent.
- Scores on the scale MADRS> 20
- Resistance Criterion defined as the failure of two antidepressants effective dose for a minimum of six weeks.
Key exclusion criteria (8 listed)
- Bipolar disorder type I or type II
- Depression With Psychotic Features
- Diagnosis according comorbid Axis I (DSM IV) with schizophrenia, alcohol abuse and / or toxic substances.
- Inpatient under stress or under legal protection measure (guardianship, curatorship)
- Counter to the practice of Transcranial Magnetic Stimulation : a personal history of seizure, history of neurological or neurosurgical pathologies, metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.).
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 - ) - MagPro®Class IIa | Device | Patients stimulated with a H-TMS (deep), Patients stimulated with a conventional TMS |
| Positon Emission Tomography (PET) - Discovery 710®Class IB | Device | Patients stimulated with a H-TMS (deep), Patients stimulated with a conventional TMS |
Primary outcome
The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).
Time frame: 24 month
performed before and after TMS
1 secondary outcome
Short self-completion questionnaire on symptoms of depression
Time frame: 24 month
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 24 May 2023.
Related trials for Pharmacoresistant Depression
Active, not recruitingObservational study
Neural Circuit Biomarkers of Transcranial Magnetic Stimulation Study
Depression
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.
Urielle DESALBRES, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS - ) - MagPro® and Positon Emission Tomography (PET) - Discovery 710® in people with Pharmacoresistant Depression, run by Assistance Publique Hopitaux De Marseille 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 6 inclusion and 8 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 24 May 2023. 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.
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 depression score in Montgomery-Åsberg Depression Rating Scale (MADRS). (time frame: 24 month). 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 24 May 2023.