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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
active rTMS-ECT
sham rTMS-ECT
Sponsored by
Centre Hospitalier du Rouvray
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring treatment-resistant-depression, rTMS, ECT, Augmentation strategy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Esquirol- CHU de Caen
  • Centre Hospitalier Laborit
  • Centre Hospitalier du Rouvray

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active rTMS-ECT

sham rTMS-ECT

Arm Description

5 active high frequency rTMS before 5 bilateral ECT

5 sham rTMS before 5 bilateral ECT

Outcomes

Primary Outcome Measures

Relative improvement of the Hamilton Rating Scale for Depression 21-items score

Secondary Outcome Measures

Full Information

First Posted
June 8, 2016
Last Updated
February 17, 2021
Sponsor
Centre Hospitalier du Rouvray
Collaborators
University Hospital, Rouen, Centre Hospitalier Henri Laborit, University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02830399
Brief Title
Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2016 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier du Rouvray
Collaborators
University Hospital, Rouen, Centre Hospitalier Henri Laborit, University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
treatment-resistant-depression, rTMS, ECT, Augmentation strategy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active rTMS-ECT
Arm Type
Active Comparator
Arm Description
5 active high frequency rTMS before 5 bilateral ECT
Arm Title
sham rTMS-ECT
Arm Type
Placebo Comparator
Arm Description
5 sham rTMS before 5 bilateral ECT
Intervention Type
Device
Intervention Name(s)
active rTMS-ECT
Intervention Description
5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
Intervention Type
Device
Intervention Name(s)
sham rTMS-ECT
Intervention Description
5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
Primary Outcome Measure Information:
Title
Relative improvement of the Hamilton Rating Scale for Depression 21-items score
Time Frame
Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Esquirol- CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Centre Hospitalier Laborit
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Centre Hospitalier du Rouvray
City
Sotteville-lès-Rouen
ZIP/Postal Code
76300
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34579796
Citation
Rotharmel M, Quesada P, Husson T, Harika-Germaneau G, Nathou C, Guehl J, Dalmont M, Opolczynski G, Mirea-Grivel I, Millet B, Gerardin E, Compere V, Dollfus S, Jaafari N, Benichou J, Thill C, Guillin O, Moulier V. The priming effect of repetitive transcranial magnetic stimulation on clinical response to electroconvulsive therapy in treatment-resistant depression: a randomized, double-blind, sham-controlled study. Psychol Med. 2023 Apr;53(5):2060-2071. doi: 10.1017/S0033291721003810. Epub 2021 Sep 28.
Results Reference
derived

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

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