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

Sponsor

Centre Hospitalier du Rouvray (Other)

Overall Status

Completed

CT.gov ID

NCT02830399

Collaborator

University Hospital, Rouen (Other), Centre Hospitalier Henri Laborit (Other), University Hospital, Caen (Other)

Enrollment

Locations

Arms

35.9

Actual Duration (Months)

18.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Device: active rTMS-ECT Device: sham rTMS-ECT	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2016

Actual Primary Completion Date :

Jul 12, 2019

Actual Study Completion Date :

Jul 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: active rTMS-ECT 5 active high frequency rTMS before 5 bilateral ECT	Device: active rTMS-ECT 5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
Placebo Comparator: sham rTMS-ECT 5 sham rTMS before 5 bilateral ECT	Device: sham rTMS-ECT 5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT

Arm

Intervention/Treatment

Active Comparator: active rTMS-ECT

5 active high frequency rTMS before 5 bilateral ECT

Device: active rTMS-ECT

5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT

Placebo Comparator: sham rTMS-ECT

5 sham rTMS before 5 bilateral ECT

Device: sham rTMS-ECT

5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Esquirol- CHU de Caen	Caen	France	14000
2	Centre Hospitalier Laborit	Poitiers	France	86000
3	Centre Hospitalier du Rouvray	Sotteville-lès-Rouen	France	76300