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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-15

Study Completion Date

2019-07-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active rTMS-ECT

5 active high frequency rTMS before 5 bilateral ECT

Group Type ACTIVE_COMPARATOR

active rTMS-ECT

Intervention Type DEVICE

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

sham rTMS-ECT

5 sham rTMS before 5 bilateral ECT

Group Type PLACEBO_COMPARATOR

sham rTMS-ECT

Intervention Type DEVICE

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

Interventions

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active rTMS-ECT

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

Intervention Type DEVICE

sham rTMS-ECT

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No