NCT02830399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

July 15, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2019

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

June 8, 2016

Last Update Submit

February 17, 2021

Conditions

Major Depressive Disorder

Keywords

treatment-resistant-depressionrTMSECTAugmentation strategy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

active rTMS-ECT

ACTIVE COMPARATOR

5 active high frequency rTMS before 5 bilateral ECT

Device: active rTMS-ECT

sham rTMS-ECT

PLACEBO COMPARATOR

5 sham rTMS before 5 bilateral ECT

Device: sham rTMS-ECT

Interventions

active rTMS-ECTDEVICE

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

active rTMS-ECT
sham rTMS-ECTDEVICE

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

sham rTMS-ECT

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Esquirol- CHU de Caen

Caen, 14000, France

Location

Centre Hospitalier Laborit

Poitiers, 86000, France

Location

Centre Hospitalier du Rouvray

Sotteville-lès-Rouen, 76300, France

Location

Related Publications (1)

  • 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.

    PMID: 34579796DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 8, 2016

First Posted

July 12, 2016

Study Start

July 15, 2016

Primary Completion

July 12, 2019

Study Completion

July 12, 2019

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)