Depression - Major Depressive DisorderLONGISTIM-BIONCT07684911
Longitudinal Study on the Sustainability of Transcranial Magnetic Stimulation Protocols - Biomarkers
An observational study of Depression - Major Depressive Disorder and Depression Bipolar, run by Hospital Center Guillaume Régnier at 1 site in France.
Trial summary
Despite advances in the effective treatment of major depressive disorder using repetitive transcranial magnetic stimulation (rTMS), the processes that determine a patient's response trajectory remain poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Depression Bipolar, Depression Unipolar
- What is being tested?
- Repetitive transcranial magnetic stimulation
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2026to Aug 2029
- Phase
- Observational
- 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
Study population: Patients undergoing a TMS course as part of clinical care at the Adult Psychiatry University Hospital Unit of the Guillaume Régnier Hospital Center.
Who may be able to join
- Patients aged 18 or older.
- Patients who have experienced treatment-resistant unipolar or bipolar depression and responded to a previous TMS course (response defined by a 50% reduction in MADRS score).
- Sufficient command of French to complete questionnaires and follow instructions during MRI assessments and TMS treatments.
- Willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study staff about adverse events and other clinically relevant information.
- Patients who have expressed their informed written consent to participate in the study.
- Person affiliated with a social welfare scheme or other scheme.
Show all 12Show fewer
- Non-inclusion Criteria:
- Current psychiatric comorbidity (suicidal risk, psychotic episode).
- Unstable somatic pathology: active cancer, unstabilized endocrinological pathology, untreated sleep apnea.
- For neuroimaging: Contraindications to magnetic resonance imaging (MRI) such as ferromagnetic metal in the body or severe claustrophobia
- Adults under legal protection (legal guardianship, conservatorship, trusteeship), persons deprived of their liberty
- Pregnancy or breast-feeding.
Who cannot join
None listed.
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 Guillaume Régnier
Rennes, 35700
Jean-Marie BATAIL, +332 99 33 39 37 ext. +33, jm.batail@ch-guillaumeregnier.fr
About this study
Despite advances in the effective treatment of major depressive disorder using repetitive transcranial magnetic stimulation (rTMS), the processes that determine a patient's response trajectory remain poorly understood.
Currently, there are no validated clinical or neurophysiological markers that can identify factors predicting the durability of the response to rTMS at the individual level. This constitutes a major limitation for planning individualised treatments and highlights the need for precision medicine approaches and reliable biomarkers to predict the long-term efficacy of TMS-based interventions, thereby enabling more informed clinical decisions and optimised resource allocation.
Read more
rTMS is assumed to work by inducing neuroplasticity on multiple levels of the nervous system, ranging from modulating neurotransmitter release to changing structural and functional brain circuits. While rTMS likely acts as a universal modulator of neuroplasticity, the exact mechanisms are not fully established, especially regarding long-term durability.
The LONGISTIM-BIO study ("Longitudinal Study on the Durability of Transcranial Magnetic Stimulation Protocols - Biomarkers") aims to explore the duration of the treatment effect following an initial response to a course of TMS treatment and examines potential neurophysiological and clinical/sociodemographic predictors associated with the trajectories of the treatment effect. More explicitly, it examines neuroplasticity as a biomarker of treatment response durability, and explores its association with heart-brain-coupling (HBC), a physiological marker of rTMS target engagement, as well as inflammation, as measured by a blood test (white blood cells, C-reactive protein (CRP)).
During this study, participants undergo an rTMS treatment as per standard clinical care. They receive daily sessions of 20Hz rTMS targeting the left dorsolateral prefrontal cortex during which the heart rate will be recorded. Before the first rTMS session, after the last session, and one month after the last session, the severity of depression is evaluated using both the MADRS and the PHQ-8 questionnaire. At the one-month follow-up, the effectiveness of the course is determined by a 50% improvement in the MADRS score. Following the 1-month follow-up visit, if meeting the inclusion criteria, patients will receive bi-weekly assessments of depression severity (PHQ-8 as primary and MADRS self-rated questionnaire as secondary outcome). If two consecutive PHQ-8 questionnaires are pathological (score ≥10), a new rTMS course is scheduled with the shortest delay possible.
During this new course of treatment, participation in the study includes:
- a blood draw prior to the first TMS session
- 4 magnetic resonance imaging (MRI) scans: #1 before the course of treatment, #2 at the end of the course, #3 one month after the end of the treatment, and #4 upon the expected date of relapse.
Patients will again be monitored using self-report questionnaires (PHQ-8 and MADRS-SR) every 2 weeks until a relapse occurs.
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- Major Depressive Disorder, Depression Bipolar, Repetitive Transcranial Magnetic Stimulation, rTMS, Depression Unipolar, Durability, Neuroplasticity, Inflammation, heart rate
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationOther
Participants receive a conventional 20Hz TMS protocol as per standard clinical care. During the 20Hz protocol, participants receive 10 daily sessions of 20 Hz rTMS (one per day over 2 weeks), each consisting of 75 trains of 40 pulses (2s per train) with a 10 seconds inter-train interval (ITI), totaling 3,000 pulses per session and 30,000 pulses over the full course. The intensity is 120% of the participant's motor threshold (MT).
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing rTMS treatment course | Not described Receives: Other: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sustainability of the antidepressant effect of a conventional 20 Hz rTMS course targeting the left left dorsolateral prefrontal cortex.
The time in weeks before depressive relapse, defined by a score of ≥10 on the 8-item version of the Patient Health Questionnaire (PHQ-8) at two successive evaluations spaced 15 days apart.
Measured: From enrollment until last assessment : 12 months
Secondary outcomes (7)
Evaluation of sociodemographic determinants associated with durability.
Measured: From enrollment until last assessment : 12 months
Evaluation of clinical determinants associated with durability.
Measured: From enrollment until last assessment : 12 months
Evaluation of therapeutic determinants associated with durability.
Measured: From enrollment until last assessment : 12 months
Evaluation of neuroplasticity as a surrogate of durability.
Neuroplasticity is estimated by MRI-derived (micro-)structural and functional metrics
Measured: From enrollment until last assessment : 12 months
Evaluation of heart-brain coupling associated with durability.
Heart-brain coupling is determined based on the heart rate during treatment (measured via ECG recording).
Measured: From enrollment until last assessment : 12 months
Evaluation of inflammation associated with durability.
C-reactive protein (CRP) levels in the blood
Measured: From enrollment until last assessment : 12 months
Assessment of TMS-induced changes in MRI-derived metrics of neuroplasticity and its correlation with treatment outcomes.
Neuroplasticity is estimated by MRI-derived (micro-)structural and functional metrics
Measured: From enrollment until last assessment : 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start4 Jun 2026
- Primary completionFeb 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Center Guillaume Régnier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684911
- Sponsor's protocol ID
- RC25_01_JMB
- Other IDs
- 2025-A02833-46
- Acronym
- LONGISTIM-BIO
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data about study protocol and clinical information will be available on request from other researchers.
Publications
Wilkening, J., Jungeblut, H. M., Adamovic, I., Belov, V., Dechent, P., Eicke, L., Hansen, N., Kozyrev, V., Marten, L. E., Muschke, Y., Riemer, C., Schnell, K., Tura, A., Wilke, M., Witteler, F., Wiltfang, J., Wunderlich, A., Zimmeck, V., Zobott, A., … Goya-Maldonado, R. (2025). Heart rate modulation and clinical improvement in major depression: A randomized clinical trial with accelerated intermittent theta burst stimulation. Brain Medicine, 1(4), 62-72. https://doi.org/10.61373/bm025a.0113
Wilkening J, Goya-Maldonado R. White matter tracts associated with iTBS-induced heart rate deceleration and treatment response in major depressive disorder. Transl Psychiatry. 2025 Oct 20;15(1):424. doi: 10.1038/s41398-025-03646-3.
PubMed 41115869Voineskos D, Daskalakis ZJ, Blumberger DM. Management of Treatment-Resistant Depression: Challenges and Strategies. Neuropsychiatr Dis Treat. 2020 Jan 21;16:221-234. doi: 10.2147/NDT.S198774. eCollection 2020.
PubMed 32021216van Rooij SJH, Arulpragasam AR, McDonald WM, Philip NS. Accelerated TMS - moving quickly into the future of depression treatment. Neuropsychopharmacology. 2024 Jan;49(1):128-137. doi: 10.1038/s41386-023-01599-z. Epub 2023 May 22.
PubMed 37217771Suneson K, Lindahl J, Chamli Harsmar S, Soderberg G, Lindqvist D. Inflammatory Depression-Mechanisms and Non-Pharmacological Interventions. Int J Mol Sci. 2021 Feb 6;22(4):1640. doi: 10.3390/ijms22041640.
PubMed 33561973Senova S, Cotovio G, Pascual-Leone A, Oliveira-Maia AJ. Durability of antidepressant response to repetitive transcranial magnetic stimulation: Systematic review and meta-analysis. Brain Stimul. 2019 Jan-Feb;12(1):119-128. doi: 10.1016/j.brs.2018.10.001. Epub 2018 Oct 2.
PubMed 30344109Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
PubMed 17074942Popovic D, Dragic M. Repetitive transcranial magnetic stimulation as a universal modulator of synaptic plasticity: Bridging the gap between functional and structural plasticity. Neurochem Int. 2025 Sep;188:106021. doi: 10.1016/j.neuint.2025.106021. Epub 2025 Jul 8.
PubMed 40639590Pedraz-Petrozzi, B., Wilkening, J., Sartorius, A., Arns, M., & Goya-Maldonado, R. (2025). White Blood Cell Count Shape Heart-Brain Coupling and rTMS Benefit in Depression. Psychiatry and Clinical Psychology. https://doi.org/10.1101/2025.09.14.25335686
Osimo EF, Baxter LJ, Lewis G, Jones PB, Khandaker GM. Prevalence of low-grade inflammation in depression: a systematic review and meta-analysis of CRP levels. Psychol Med. 2019 Sep;49(12):1958-1970. doi: 10.1017/S0033291719001454. Epub 2019 Jul 1.
PubMed 31258105Ning L, Rathi Y, Barbour T, Makris N, Camprodon JA. White matter markers and predictors for subject-specific rTMS response in major depressive disorder. J Affect Disord. 2022 Feb 15;299:207-214. doi: 10.1016/j.jad.2021.12.005. Epub 2021 Dec 4.
PubMed 34875281McIntyre RS, Alsuwaidan M, Baune BT, Berk M, Demyttenaere K, Goldberg JF, Gorwood P, Ho R, Kasper S, Kennedy SH, Ly-Uson J, Mansur RB, McAllister-Williams RH, Murrough JW, Nemeroff CB, Nierenberg AA, Rosenblat JD, Sanacora G, Schatzberg AF, Shelton R, Stahl SM, Trivedi MH, Vieta E, Vinberg M, Williams N, Young AH, Maj M. Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions. World Psychiatry. 2023 Oct;22(3):394-412. doi: 10.1002/wps.21120.
PubMed 37713549Liu B, Liu J, Wang M, Zhang Y, Li L. From Serotonin to Neuroplasticity: Evolvement of Theories for Major Depressive Disorder. Front Cell Neurosci. 2017 Sep 28;11:305. doi: 10.3389/fncel.2017.00305. eCollection 2017.
PubMed 29033793Liston C, Chen AC, Zebley BD, Drysdale AT, Gordon R, Leuchter B, Voss HU, Casey BJ, Etkin A, Dubin MJ. Default mode network mechanisms of transcranial magnetic stimulation in depression. Biol Psychiatry. 2014 Oct 1;76(7):517-26. doi: 10.1016/j.biopsych.2014.01.023. Epub 2014 Feb 5.
PubMed 24629537Lan MJ, Chhetry BT, Liston C, Mann JJ, Dubin M. Transcranial Magnetic Stimulation of Left Dorsolateral Prefrontal Cortex Induces Brain Morphological Changes in Regions Associated with a Treatment Resistant Major Depressive Episode: An Exploratory Analysis. Brain Stimul. 2016 Jul-Aug;9(4):577-83. doi: 10.1016/j.brs.2016.02.011. Epub 2016 Mar 2.
PubMed 27017072
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study on the Sustainability of Transcranial Magnetic Stimulation Protocols - Biomarkers
- ClinicalTrials.gov ID
- NCT07684911
- Acronym / sponsor ID
- LONGISTIM-BIO / RC25_01_JMB
- Keywords
- Major Depressive Disorder, Depression Bipolar, Repetitive Transcranial Magnetic Stimulation, rTMS, Depression Unipolar, Durability, Neuroplasticity, Inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Center Guillaume RégnierUniversity, hospital or other
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 6 Jul 2026 (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.
Despite advances in the effective treatment of major depressive disorder using repetitive transcranial magnetic stimulation (rTMS), the processes that determine a patient's response trajectory remain poorly understood.
Currently, there are no validated clinical or neurophysiological markers that can identify factors predicting the durability of the response to rTMS at the individual level. This constitutes a major limitation for planning individualised treatments and highlights the need for precision medicine approaches and reliable biomarkers to predict the long-term efficacy of TMS-based interventions, thereby enabling more informed clinical decisions and optimised resource allocation.
rTMS is assumed to work by inducing neuroplasticity on multiple levels of the nervous system, ranging from modulating neurotransmitter release to changing structural and functional brain circuits. While rTMS likely acts as a universal modulator of neuroplasticity, the exact mechanisms are not fully established, especially regarding long-term durability.
The LONGISTIM-BIO study ("Longitudinal Study on the Durability of Transcranial Magnetic Stimulation Protocols - Biomarkers") aims to explore the duration of the treatment effect following an initial response to a course of TMS treatment and examines potential neurophysiological and clinical/sociodemographic predictors associated with the trajectories of the treatment effect. More explicitly, it examines neuroplasticity as a biomarker of treatment response durability, and explores its association with heart-brain-coupling (HBC), a physiological marker of rTMS target engagement, as well as inflammation, as measured by a blood test (white blood cells, C-reactive protein (CRP)).
During this study, participants undergo an rTMS treatment as per standard clinical care. They receive daily sessions of 20Hz rTMS targeting the left dorsolateral prefrontal cortex during which the heart rate will be recorded. Before the first rTMS session, after the last session, and one month after the last session, the severity of depression is evaluated using both the MADRS and the PHQ-8 questionnaire. At the one-month follow-up, the effectiveness of the course is determined by a 50% improvement in the MADRS score. Following the 1-month follow-up visit, if meeting the inclusion criteria, patients will receive bi-weekly assessments of depression severity (PHQ-8 as primary and MADRS self-rated questionnaire as secondary outcome). If two consecutive PHQ-8 questionnaires are pathological (score ≥10), a new rTMS course is scheduled with the shortest delay possible.
During this new course of treatment, participation in the study includes:
- a blood draw prior to the first TMS session
- 4 magnetic resonance imaging (MRI) scans: #1 before the course of treatment, #2 at the end of the course, #3 one month after the end of the treatment, and #4 upon the expected date of relapse.
Patients will again be monitored using self-report questionnaires (PHQ-8 and MADRS-SR) every 2 weeks until a relapse occurs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing rTMS treatment course | – | Other: Repetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a TMS course as part of clinical care at the Adult Psychiatry University Hospital Unit of the Guillaume Régnier Hospital Center.
Key inclusion criteria (12 listed)
- Patients aged 18 or older.
- Patients who have experienced treatment-resistant unipolar or bipolar depression and responded to a previous TMS course (response defined by a 50% reduction in MADRS score).
- Sufficient command of French to complete questionnaires and follow instructions during MRI assessments and TMS treatments.
- Willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study staff about adverse events and other clinically relevant information.
- Patients who have expressed their informed written consent to participate in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationParticipants receive a conventional 20Hz TMS protocol as per standard clinical care. During the 20Hz protocol, participants receive 10 daily sessions of 20 Hz rTMS (one per day over 2 weeks), each consisting of 75 trains of 40 pulses (2s per train) with a 10 seconds inter-train interval (ITI), totaling 3,000 pulses per session and 30,000 pulses over the full course. The intensity is 120% of the participant's motor threshold (MT). | Other | Patients undergoing rTMS treatment course |
Primary outcome
The sustainability of the antidepressant effect of a conventional 20 Hz rTMS course targeting the left left dorsolateral prefrontal cortex.
Time frame: From enrollment until last assessment : 12 months
The time in weeks before depressive relapse, defined by a score of ≥10 on the 8-item version of the Patient Health Questionnaire (PHQ-8) at two successive evaluations spaced 15 days apart.
7 secondary outcomes
Evaluation of sociodemographic determinants associated with durability.
Time frame: From enrollment until last assessment : 12 months
Evaluation of clinical determinants associated with durability.
Time frame: From enrollment until last assessment : 12 months
Evaluation of therapeutic determinants associated with durability.
Time frame: From enrollment until last assessment : 12 months
Evaluation of neuroplasticity as a surrogate of durability.
Time frame: From enrollment until last assessment : 12 months
Evaluation of heart-brain coupling associated with durability.
Time frame: From enrollment until last assessment : 12 months
Evaluation of inflammation associated with durability.
Time frame: From enrollment until last assessment : 12 months
Assessment of TMS-induced changes in MRI-derived metrics of neuroplasticity and its correlation with treatment outcomes.
Time frame: From enrollment until last assessment : 12 months
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 6 Jul 2026.
- BackgroundWilkening, J., Jungeblut, H. M., Adamovic, I., Belov, V., Dechent, P., Eicke, L., Hansen, N., Kozyrev, V., Marten, L. E., Muschke, Y., Riemer, C., Schnell, K., Tura, A., Wilke, M., Witteler, F., Wiltfang, J., Wunderlich, A., Zimmeck, V., Zobott, A., … Goya-Maldonado, R. (2025). Heart rate modulation and clinical improvement in major depression: A randomized clinical trial with accelerated intermittent theta burst stimulation. Brain Medicine, 1(4), 62-72. https://doi.org/10.61373/bm025a.0113
- Background: PubMed 41115869Wilkening J, Goya-Maldonado R. White matter tracts associated with iTBS-induced heart rate deceleration and treatment response in major depressive disorder. Transl Psychiatry. 2025 Oct 20;15(1):424. doi: 10.1038/s41398-025-03646-3.
- Background: PubMed 32021216Voineskos D, Daskalakis ZJ, Blumberger DM. Management of Treatment-Resistant Depression: Challenges and Strategies. Neuropsychiatr Dis Treat. 2020 Jan 21;16:221-234. doi: 10.2147/NDT.S198774. eCollection 2020.
- Background: PubMed 37217771van Rooij SJH, Arulpragasam AR, McDonald WM, Philip NS. Accelerated TMS - moving quickly into the future of depression treatment. Neuropsychopharmacology. 2024 Jan;49(1):128-137. doi: 10.1038/s41386-023-01599-z. Epub 2023 May 22.
- Background: PubMed 33561973Suneson K, Lindahl J, Chamli Harsmar S, Soderberg G, Lindqvist D. Inflammatory Depression-Mechanisms and Non-Pharmacological Interventions. Int J Mol Sci. 2021 Feb 6;22(4):1640. doi: 10.3390/ijms22041640.
- Background: PubMed 30344109Senova S, Cotovio G, Pascual-Leone A, Oliveira-Maia AJ. Durability of antidepressant response to repetitive transcranial magnetic stimulation: Systematic review and meta-analysis. Brain Stimul. 2019 Jan-Feb;12(1):119-128. doi: 10.1016/j.brs.2018.10.001. Epub 2018 Oct 2.
- Background: PubMed 17074942Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
- Background: PubMed 40639590Popovic D, Dragic M. Repetitive transcranial magnetic stimulation as a universal modulator of synaptic plasticity: Bridging the gap between functional and structural plasticity. Neurochem Int. 2025 Sep;188:106021. doi: 10.1016/j.neuint.2025.106021. Epub 2025 Jul 8.
- BackgroundPedraz-Petrozzi, B., Wilkening, J., Sartorius, A., Arns, M., & Goya-Maldonado, R. (2025). White Blood Cell Count Shape Heart-Brain Coupling and rTMS Benefit in Depression. Psychiatry and Clinical Psychology. https://doi.org/10.1101/2025.09.14.25335686
- Background: PubMed 31258105Osimo EF, Baxter LJ, Lewis G, Jones PB, Khandaker GM. Prevalence of low-grade inflammation in depression: a systematic review and meta-analysis of CRP levels. Psychol Med. 2019 Sep;49(12):1958-1970. doi: 10.1017/S0033291719001454. Epub 2019 Jul 1.
- Background: PubMed 34875281Ning L, Rathi Y, Barbour T, Makris N, Camprodon JA. White matter markers and predictors for subject-specific rTMS response in major depressive disorder. J Affect Disord. 2022 Feb 15;299:207-214. doi: 10.1016/j.jad.2021.12.005. Epub 2021 Dec 4.
- Background: PubMed 37713549McIntyre RS, Alsuwaidan M, Baune BT, Berk M, Demyttenaere K, Goldberg JF, Gorwood P, Ho R, Kasper S, Kennedy SH, Ly-Uson J, Mansur RB, McAllister-Williams RH, Murrough JW, Nemeroff CB, Nierenberg AA, Rosenblat JD, Sanacora G, Schatzberg AF, Shelton R, Stahl SM, Trivedi MH, Vieta E, Vinberg M, Williams N, Young AH, Maj M. Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions. World Psychiatry. 2023 Oct;22(3):394-412. doi: 10.1002/wps.21120.
- Individual participant dataSharing planned: No. Data about study protocol and clinical information will be available on request from other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder and Depression Bipolar, run by Hospital Center Guillaume Régnier 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 12 inclusion and 0 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 6 Jul 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 Jean-Marie BATAIL (+332 99 33 39 37 ext. +33, jm.batail@ch-guillaumeregnier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sustainability of the antidepressant effect of a conventional 20 Hz rTMS course targeting the left left dorsolateral prefrontal cortex. (time frame: From enrollment until last assessment : 12 months). 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 NCT07684911, which also lists 35 linked publications.
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 Jul 2026.