Clinical, Cognitive and Neural Effects of Potentiation of ECT by rTMS in Treatment-Resistant Depr… (NCT06391723) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical, Cognitive and Neural Effects of Potentiation of ECT by rTMS in Treatment-Resistant Depression
80 participantsStarted 2024-06
Plain-language 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. 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* 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
* Without benzodiazepine or antiepileptic treatment for at least 15 days
* To understand spoken and written French
* Having given their informed, written consent
Exclusion Criteria:
* 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
* 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 participa…