Clinical, Cognitive and Neural Effects of Potentiation of ECT by rTMS in Treatment-Resistant Depression
NCT ID: NCT06391723
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2024-06-30
2026-09-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active rTMS group
5 active rTMS before starting ECT, then from the sixth ECT session, an active rTMS session will occur the day before each ECT session
Active rTMS
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 rTMS group
5 sham rTMS before starting ECT, then from the sixth ECT session, a sham rTMS session will occur the day before each ECT session
Sham rTMS
Sham rTMS will be administered over the left dorsolateral prefrontal cortex
Interventions
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Active rTMS
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 rTMS
Sham rTMS will be administered over the left dorsolateral prefrontal cortex
Eligibility Criteria
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Inclusion 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
* Without benzodiazepine or antiepileptic treatment for at least 15 days
* To understand spoken and written French
* Having given their informed, written consent
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Centre Hospitalier Sainte Anne, Paris
UNKNOWN
Centre Hospitalier du Rouvray
OTHER_GOV
Responsible Party
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Maud Rothärmel
Principal investigator
Central Contacts
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Other Identifiers
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2023-A01813-42
Identifier Type: -
Identifier Source: org_study_id