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

Last updated: February 17, 2021
Sponsor: Centre Hospitalier du Rouvray
Overall Status: Completed

Phase

N/A

Condition

Affective Disorders

Depression (Major/severe)

Depression

Treatment

N/A

Clinical Study ID

NCT02830399
2015-A01810-49
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 56
Study Start date:
July 15, 2016
Estimated Completion Date:
July 12, 2019

Study 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.

Connect with a study center

  • Centre Esquirol- CHU de Caen

    Caen, 14000
    France

    Site Not Available

  • Centre Hospitalier Laborit

    Poitiers, 86000
    France

    Site Not Available

  • Centre Hospitalier du Rouvray

    Sotteville-lès-Rouen, 76300
    France

    Site Not Available

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