Clinical, Cognitive and Neural Effects of Potentiation of ECT by rTMS in Treatment-Resistant Depression

NCT06391723 | Not Yet Recruiting

• 1 other identifier: 2023-A01813-42
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Treatment-resistant-depression; repetitive transcranial magnetic stimulation (rTMS); electroconvulsive therapy (ECT); combination of neurostimulation techniques

Outcome Measures

Primary Outcomes (1)

• 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)

  Day 0 and Day 40

Secondary Outcomes (17)

• The relative improvement of depressive symptoms throughout the study (assessed by a clinician)

  Day 0, Day 4, Day 19, Day 26, Day 40

• The relative improvement of depressive symptoms throughout the study (self-reported)

  Day 0, Day 4, Day 19, Day 26, Day 40

• Adverse effects

  Day 4, Day 19, Day 26, Day 40

• Subjective assessment of memory

  Day 4, Day 19, Day 26, Day 40

• Subjective assessment of cognitive functioning

  Day 4, Day 19, Day 26, Day 40

Study Arms (2)

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

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

Device: Sham rTMS

Interventions

Active rTMS DEVICE

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)

Active rTMS group

Sham rTMS DEVICE

Sham rTMS will be administered over the left dorsolateral prefrontal cortex

Sham rTMS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier du Rouvray: lead
• University Hospital, Rouen: collaborator
• Centre Hospitalier Sainte Anne, Paris: collaborator

Related Publications (1)

• 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. doi: 10.1186/s13063-025-09406-4. Online ahead of print.

  PMID: 41582128 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Maud Rotharmel

CONTACT

+33232956825; maud.rotharmel@ch-lerouvray.fr

Virginie Moulier

CONTACT

virginie.moulier@ch-lerouvray.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Multicenter, randomized, double-blind, sham-controlled trial

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: April 30, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share