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

Major Depressive Disorder Clinical Trial

— STIMAGNECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830399
• Other study ID #: 2015-A01810-49
• Status: Completed
• Phase: N/A
• Start date: July 15, 2016
• Est. completion date: July 12, 2019

Study information

• Verified date: February 2021
• Source: Centre Hospitalier du Rouvray
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with Major Depressive Disorder (HAMD=15)
• Level of resistance = 3 (Thase and Rush)
• Participants who gave their informed, written consent

Exclusion Criteria:

• Contraindication of Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
• History of epilepsy; severe neurological or systemic disorder that could significantly affect cognition
• Pregnancy

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Intervention

Device:
• active rTMS-ECT
5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
• sham rTMS-ECT
5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT

Locations

Country	Name	City	State
France	Centre Esquirol- CHU de Caen	Caen
France	Centre Hospitalier Laborit	Poitiers
France	Centre Hospitalier du Rouvray	Sotteville-lès-Rouen

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier du Rouvray	Centre Hospitalier Henri Laborit, University Hospital, Caen, University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative improvement of the Hamilton Rating Scale for Depression 21-items score		Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion