Depressive Disorder, Treatment-ResistantHAUVERDEEPNCT04956016
Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
A study testing classic rTMS using the 8-shaped coil and deep rTMS using the H1-shaped coil in people with Depressive Disorder, Treatment-Resistant, run by Centre Hospitalier Henri Laborit at 1 site in France.
Trial summary
The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. The patient will receive treatment arm A or B : Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- What is being tested?
- classic rTMS using the 8-shaped coil and deep rTMS using the H1-shaped coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2021to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Volunteer subjects over 18 years old
- Having signed a free and informed consent
- Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994).
- Having an antidepressant treatment not modified since 3 weeks
- Score to MADRS scale ≥ 21
- Subject affiliated to a social security regimen
Who cannot join
- Depression with psychotic caracteristics
- Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime)
- Patient who has already undergone seismotherapy for current episode and non-responder to this treatment
- Patient hospitalized under duress or under legal protection (guardianship, curatorship)
- Patient with a high risk of suicide (item 10 of MADRS > 4) in the absence of hospitalization.
- Contra-indication for IRM exam or rTMS : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip
- Pregnancy
- Simultaneous participation to another interventionnal study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Henri Laborit
Poitiers
Ghina Harika-Germaneau, MD, PhD
About this study
Official title: Open-label Randomized Comparative Study of the Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment in the Management of Resistant Depression
The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil.
The patient will receive treatment arm A or B :
Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies.
20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Being tested
- classic rTMS using the 8-shaped coil, deep rTMS using the H1-shaped coil
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classic rTMS using the 8-shaped coilDevice
20 rTMS sessions are planned (5 sessions per week)
deep rTMS using the H1-shaped coilDevice
20 rTMS sessions are planned (5 sessions per week)
| Study group | Role | What they receive |
|---|---|---|
| classic rTMS treatment | Active comparator | Arm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy Receives: Device: classic rTMS using the 8-shaped coil |
| treatment with deep rTMS | Active comparator | Arm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies Receives: Device: deep rTMS using the H1-shaped coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
A 50% change of MADRS score
The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil.
Modification of the MADRS score compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score >34 being severe depression.
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start23 Aug 2021
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, Treatment-ResistantStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghina HARIKA-GERMANEAU, Dr, Principal investigator, Centre Hospitalier Henri Laborit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956016
- Sponsor's protocol ID
- 2021-A00796-35
- Acronym
- HAUVERDEEP
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2021
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized Comparative Study of the Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment in the Management of Resistant Depression
- ClinicalTrials.gov ID
- NCT04956016
- Acronym / sponsor ID
- HAUVERDEEP / 2021-A00796-35
- Conditions
- Depressive Disorder, Treatment-Resistant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Jul 2021 (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.
The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil.
The patient will receive treatment arm A or B :
Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies.
20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic rTMS treatment | Active comparator | Device: classic rTMS using the 8-shaped coilArm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy |
| treatment with deep rTMS | Active comparator | Device: deep rTMS using the H1-shaped coilArm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteer subjects over 18 years old
- Having signed a free and informed consent
- Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994).
- Having an antidepressant treatment not modified since 3 weeks
- Score to MADRS scale ≥ 21
Key exclusion criteria (8 listed)
- Depression with psychotic caracteristics
- Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime)
- Patient who has already undergone seismotherapy for current episode and non-responder to this treatment
- Patient hospitalized under duress or under legal protection (guardianship, curatorship)
- Patient with a high risk of suicide (item 10 of MADRS > 4) in the absence of hospitalization.
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 |
|---|---|---|
| classic rTMS using the 8-shaped coil20 rTMS sessions are planned (5 sessions per week) | Device | classic rTMS treatment |
| deep rTMS using the H1-shaped coil20 rTMS sessions are planned (5 sessions per week) | Device | treatment with deep rTMS |
Primary outcome
A 50% change of MADRS score
Time frame: Day 60
The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. Modification of the MADRS score compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score >34 being severe depression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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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.
Ghina HARIKA-GERMANEAU, Dr principal investigator
Centre Hospitalier Henri Laborit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classic rTMS using the 8-shaped coil and deep rTMS using the H1-shaped coil in people with Depressive Disorder, Treatment-Resistant, run by Centre Hospitalier Henri Laborit 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghina HARIKA-GERMANEAU, Dr (0033 5 16 52 61 18, ghina.harika-germaneau@ch-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A 50% change of MADRS score (time frame: Day 60). 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 13 Jan 2026.