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

February 17, 2021 updated by: Maud Rothärmel, Centre Hospitalier du Rouvray

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Centre Esquirol- CHU de Caen
      • Poitiers, France, 86000
        • Centre Hospitalier Laborit
      • Sotteville-lès-Rouen, France, 76300
        • Centre Hospitalier du Rouvray

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier du Rouvray

Collaborators

University Hospital, Rouen
University Hospital, Caen
Centre Hospitalier Henri Laborit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2016

Primary Completion (Actual)

July 12, 2019

Study Completion (Actual)

July 12, 2019

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01810-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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