Major Depressive DisorderSTIMAGNECT2NCT06391723
Clinical, Cognitive and Neural Effects of Potentiation of ECT by rTMS in Treatment-Resistant Depression
A study testing Active rTMS in people with Major Depressive Disorder, run by Centre Hospitalier du Rouvray.
Trial summary
Electroconvulsive therapy (ECT) is one of the most effective treatments for treatment-resistant depression (TRD). However, due to response delay and cognitive impairment, ECT remains an imperfect treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Sep 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- HAMD score ≥15
- In case of unipolar disorder: no remission after at least two different antidepressants prescribed at a dose and duration sufficient for the current episode
- In the case of bipolar disorder: no remission despite lithium at an adequate plasma level combined with lamotrigine or quetiapine monotherapy at full dose
- No change of antidepressant or mood stabilizer treatment for at least 15 days
- To be rTMS-naive
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- Without benzodiazepine or antiepileptic treatment for at least 15 days
- To understand spoken and written French
- Having given their informed, written consent
Who cannot join
- Contraindication to Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
- Patients who have received ECT in the last 6 months
- Patients suffering from poorly stabilized epilepsy, serious neurological or systemic disorders
- Patients with a serious substance use disorder (other than nicotine or caffeine) according to DSM-5 criteria
- Patients suffering from severe hearing problems
- Subjects already treated with an electrical or magnetic stimulation technique
Show all 9Show fewer
- Women who do not have adequate contraception, pregnant or breastfeeding women
- Being deprived of liberty by an administrative or judicial decision
- Patients participating or having participated in an interventional clinical trial within 30 days before the inclusion visit
Trial locations and contacts
No sites are listed yet.
Virginie Moulier contact
About this study
Official title: Clinical, Cognitive and Neural Effect of Potentiation of Electroconvulsive Therapy (ECT) by Repetitive Transcranial Magnetic Stimulation (rTMS) at 10 ECT in Patients With Characterized Pharmacoresistant Depressive Episode
Electroconvulsive therapy (ECT) is one of the most effective treatments for treatment-resistant depression (TRD). However, due to response delay and cognitive impairment, ECT remains an imperfect treatment. In this multicenter, randomized, double-blind, sham-controlled study, our objective is to assess the priming effect of rTMS sessions before ECT on clinical, cognitive and neural response in patients with TRD.
Read the detailed description
80 patients with TRD will be assigned to active or sham rTMS before ECT treatment. Five sessions of active/sham rTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session) before ECT (which was active for all patients) started. Then, from the sixth ECT session, an rTMS session will occur the day before each ECT session. Clinical assessment, cognitive assessment and brain imaging (structural MRI, resting state functional MRI, MR spectroscopy) will take place before and after 10 ECT sessions. Clinical, cognitive and neural changes will be compared between both groups after 10 ECT sessions.
The primary outcome will be the response rate after 10 ECT, i.e. the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items).
- Conditions
- Major Depressive Disorder
- Being tested
- Active rTMS, Sham rTMS
- Keywords
- Treatment-resistant-depression, repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT), combination of neurostimulation techniques
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
rTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session)
Sham rTMSDevice
Sham rTMS will be administered over the left dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS group | Active comparator | 5 active rTMS before starting ECT, then from the sixth ECT session, an active rTMS session will occur the day before each ECT session Receives: Device: Active rTMS |
| Sham rTMS group | Placebo comparator | 5 sham rTMS before starting ECT, then from the sixth ECT session, a sham rTMS session will occur the day before each ECT session Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate after 10 ECT
the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items)
Measured: Day 0 and Day 40
Secondary outcomes (17)
The relative improvement of depressive symptoms throughout the study (assessed by a clinician)
the relative variation of HAMD-21
Measured: Day 0, Day 4, Day 19, Day 26, Day 40
The relative improvement of depressive symptoms throughout the study (self-reported)
Quick Inventory of Depressive Symptomatology
Measured: Day 0, Day 4, Day 19, Day 26, Day 40
Adverse effects
Assessment of adverse effects with the Udvalg for Kliniske Undersogelser (UKU) side effects rating scale adapted to rTMS (adapted UKU)
Measured: Day 4, Day 19, Day 26, Day 40
Subjective assessment of memory
Scores and variations in memory assessed with the Squire Subjective Memory Questionnaire (SSMQ)
Measured: Day 4, Day 19, Day 26, Day 40
Subjective assessment of cognitive functioning
Scores and variations in cognitive functioning assessed with the Cognitive Failures Questionnaire (CFQ)
Measured: Day 4, Day 19, Day 26, Day 40
Global cognitive functioning (objective)
Scores and variations assessed with the Mini Mental Status Examination
Measured: Day 0 and Day 40
Verbal memory performances (objective)
Scores and variations assessed with the RL/RI-16 test
Measured: Day 0 and Day 40
Attention (objective)
Scores and variations assessed the D2 test of attention
Measured: Day 0 and Day 40
Visuospatial and constructional ability (objective)
Scores and variations assessed with the Rey-Osterrieth complex figure test
Measured: Day 0 and Day 40
Autobiographical memory (objective)
Scores and variations assessed with the autobiographical memory test (TEMPau)
Measured: Day 0 and Day 40
Seizure threshold
Seizure threshold during ECT
Measured: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Seizure duration
Seizure duration during ECT
Measured: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Postictal Suppression
Postictal Suppression during ECT
Measured: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Dose of medication
Dose of medication during ECT
Measured: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Changes in regional gray matter density
Changes in regional gray matter density measured with 3D MRI
Measured: Day 0 and Day 40
Changes in cortical thickness
Changes in cortical thickness measured with 3D MRI
Measured: Day 0 and Day 40
Brain activity and biochemical changes
Changes measured with Resting state functional MRI and spectroscopy MRI
Measured: Day 0 and Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, double-blind, sham-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Rouvray
- Sponsor type
- Other government
- Collaborators
- University Hospital, Rouen, Centre Hospitalier Sainte Anne, Paris
- Responsible party
- Principal investigator, Maud Rothärmel, Centre Hospitalier du Rouvray
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391723
- Sponsor's protocol ID
- 2023-A01813-42
- Acronym
- STIMAGNECT2
- Status last verified
- Apr 2024
- First submitted
- 30 Jan 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clabeau L, Moulier V, Kaczmarek B, Dalmont M, Batail JM, Bouaziz N, Brunelin J, Calvet B, Daudet C, Dollfus S, Domenech P, Drapier D, Galvao F, Gohier B, Harika-Germaneau G, Holtzmann J, Jaafari N, Jalenques I, Januel D, Kazour F, Laurin A, Letourneur F, Pouchon A, Samalin L, Sauvaget A, Szekely D, Vinckier F, Le Clezio C, Compere V, Gerardin E, Guillin O, Quesada P, Rotharmel M. A prospective multicentre double-blind randomized controlled trial evaluating clinical, cognitive and neural effects of potentiation of electroconvulsive therapy by repetitive transcranial magnetic stimulation in patients with treatment-resistant depression (STIMAGNECT 2). Trials. 2026 Jan 26;27(1):149. doi: 10.1186/s13063-025-09406-4.
PubMed 41582128
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Cognitive and Neural Effect of Potentiation of Electroconvulsive Therapy (ECT) by Repetitive Transcranial Magnetic Stimulation (rTMS) at 10 ECT in Patients With Characterized Pharmacoresistant Depressive Episode
- ClinicalTrials.gov ID
- NCT06391723
- Acronym / sponsor ID
- STIMAGNECT2 / 2023-A01813-42
- Conditions
- Major Depressive Disorder
- Keywords
- Treatment-resistant-depression, repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT), combination of neurostimulation techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier du RouvrayOther government
- Collaborators
- University Hospital, Rouen, Centre Hospitalier Sainte Anne, Paris
- Study start
- Jun 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 30 Apr 2024 (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.
Electroconvulsive therapy (ECT) is one of the most effective treatments for treatment-resistant depression (TRD). However, due to response delay and cognitive impairment, ECT remains an imperfect treatment. In this multicenter, randomized, double-blind, sham-controlled study, our objective is to assess the priming effect of rTMS sessions before ECT on clinical, cognitive and neural response in patients with TRD.
Detailed description
80 patients with TRD will be assigned to active or sham rTMS before ECT treatment. Five sessions of active/sham rTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session) before ECT (which was active for all patients) started. Then, from the sixth ECT session, an rTMS session will occur the day before each ECT session. Clinical assessment, cognitive assessment and brain imaging (structural MRI, resting state functional MRI, MR spectroscopy) will take place before and after 10 ECT sessions. Clinical, cognitive and neural changes will be compared between both groups after 10 ECT sessions.
The primary outcome will be the response rate after 10 ECT, i.e. the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, randomized, double-blind, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active rTMS group | Active comparator | Device: Active rTMS5 active rTMS before starting ECT, then from the sixth ECT session, an active rTMS session will occur the day before each ECT session |
| Sham rTMS group | Placebo comparator | Device: Sham rTMS5 sham rTMS before starting ECT, then from the sixth ECT session, a sham rTMS session will occur the day before each ECT session |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- HAMD score ≥15
- In case of unipolar disorder: no remission after at least two different antidepressants prescribed at a dose and duration sufficient for the current episode
- In the case of bipolar disorder: no remission despite lithium at an adequate plasma level combined with lamotrigine or quetiapine monotherapy at full dose
- No change of antidepressant or mood stabilizer treatment for at least 15 days
Key exclusion criteria (9 listed)
- Contraindication to Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
- Patients who have received ECT in the last 6 months
- Patients suffering from poorly stabilized epilepsy, serious neurological or systemic disorders
- Patients with a serious substance use disorder (other than nicotine or caffeine) according to DSM-5 criteria
- Patients suffering from severe hearing problems
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 |
|---|---|---|
| Active rTMSrTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session) | Device | Active rTMS group |
| Sham rTMSSham rTMS will be administered over the left dorsolateral prefrontal cortex | Device | Sham rTMS group |
Primary outcome
Response rate after 10 ECT
Time frame: Day 0 and Day 40
the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items)
17 secondary outcomes
The relative improvement of depressive symptoms throughout the study (assessed by a clinician)
Time frame: Day 0, Day 4, Day 19, Day 26, Day 40
The relative improvement of depressive symptoms throughout the study (self-reported)
Time frame: Day 0, Day 4, Day 19, Day 26, Day 40
Adverse effects
Time frame: Day 4, Day 19, Day 26, Day 40
Subjective assessment of memory
Time frame: Day 4, Day 19, Day 26, Day 40
Subjective assessment of cognitive functioning
Time frame: Day 4, Day 19, Day 26, Day 40
Global cognitive functioning (objective)
Time frame: Day 0 and Day 40
Verbal memory performances (objective)
Time frame: Day 0 and Day 40
Attention (objective)
Time frame: Day 0 and Day 40
Visuospatial and constructional ability (objective)
Time frame: Day 0 and Day 40
Autobiographical memory (objective)
Time frame: Day 0 and Day 40
Seizure threshold
Time frame: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Seizure duration
Time frame: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Postictal Suppression
Time frame: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Dose of medication
Time frame: Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37
Changes in regional gray matter density
Time frame: Day 0 and Day 40
Changes in cortical thickness
Time frame: Day 0 and Day 40
Brain activity and biochemical changes
Time frame: Day 0 and Day 40
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 41582128Clabeau L, Moulier V, Kaczmarek B, Dalmont M, Batail JM, Bouaziz N, Brunelin J, Calvet B, Daudet C, Dollfus S, Domenech P, Drapier D, Galvao F, Gohier B, Harika-Germaneau G, Holtzmann J, Jaafari N, Jalenques I, Januel D, Kazour F, Laurin A, Letourneur F, Pouchon A, Samalin L, Sauvaget A, Szekely D, Vinckier F, Le Clezio C, Compere V, Gerardin E, Guillin O, Quesada P, Rotharmel M. A prospective multicentre double-blind randomized controlled trial evaluating clinical, cognitive and neural effects of potentiation of electroconvulsive therapy by repetitive transcranial magnetic stimulation in patients with treatment-resistant depression (STIMAGNECT 2). Trials. 2026 Jan 26;27(1):149. doi: 10.1186/s13063-025-09406-4.
- Individual participant dataSharing planned: No
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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.
Virginie Moulier contact
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS in people with Major Depressive Disorder, run by Centre Hospitalier du Rouvray.
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maud Rotharmel (+33232956825, maud.rotharmel@ch-lerouvray.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate after 10 ECT (time frame: Day 0 and Day 40). 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 NCT06391723, 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 30 Apr 2024.