NCT02830399

Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression

Clinical Trial on Efficacy of Repeated Transcranial Magnetic Stimulation (rTMS) to Improve Electroconvulsive Therapy (ECT) in Treatment-Resistant Depression (TRD): STIMAGNECT Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Centre Hospitalier du Rouvray · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

It's a prospective, multicentric, randomized, controlled study concerning 56 patients with treatment-resistant depression (TRD). The main objective of this study was to evaluate the efficacy of priming repeated Transcranial Magnetic Stimulation (rTMS) sessions before Electroconvulsive therapy (ECT) for treatment of TRD patients. The primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association.

Detailed description

Included patients are adults, aged between 18 and 70 years, with major depression (Hamilton Rating scale for Depression, HAMD ≥ 15). Patients don't have any experience concerning repeated Transcranial Magnetic Stimulation (rTMS). Patients with treatment-resistant depression (TRD) were assigned to two treatment groups in addition to their current pharmacotherapy regimen : one group received 5 active-rTMS before Electroconvulsive therapy (ECT) and the other one received sham-rTMS before ECT. The depressive symptoms and the cognitive functions are evaluated before rTMS, after 5 rTMS and after 5 ECT.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	active rTMS-ECT	5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
DEVICE	sham rTMS-ECT	5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT

Timeline

• Start date: 2016-07-15
• Primary completion: 2019-07-12
• Completion: 2019-07-12
• First posted: 2016-07-12
• Last updated: 2021-02-18

Locations

3 sites across 1 country: France