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

NCT02830399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-02-18

No results posted yet for this 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.

Conditions

Interventions

DEVICE

active rTMS-ECT

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

DEVICE

sham rTMS-ECT

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

Sponsors & Collaborators

  • University Hospital, Rouen

    collaborator OTHER

  • Centre Hospitalier Henri Laborit

    collaborator OTHER

  • University Hospital, Caen

    collaborator OTHER

  • Centre Hospitalier du Rouvray

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-15
Primary Completion
2019-07-12
Completion
2019-07-12

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02830399 on ClinicalTrials.gov