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Efficacy of two intensive and spaced protocols of theta burst transcranial magnetic stimulation in treatment-resistant depression: a double-blind randomized trial

Published online by Cambridge University Press:  19 July 2023

Y. Cañada ,
P. Navalón ,
P. Benavent ,
A. Sabater ,
J. Ribes ,
L. Livianos  and
P. Sierra
Y. Cañada*
Affiliation:
Mental Health Group, La Fe Health Research Institute Psychiatry, La Fe University and Polytechnic Hospital, Valencia, Spain
P. Navalón
Affiliation:
Psychiatry, La Fe University and Polytechnic Hospital, Valencia, Spain
P. Benavent
Affiliation:
Psychiatry, La Fe University and Polytechnic Hospital, Valencia, Spain
A. Sabater
Affiliation:
Psychiatry, La Fe University and Polytechnic Hospital, Valencia, Spain
J. Ribes
Affiliation:
Psychiatry, La Fe University and Polytechnic Hospital, Valencia, Spain
L. Livianos
Affiliation:
Psychiatry, La Fe University and Polytechnic Hospital, Valencia, Spain
P. Sierra
Affiliation:
Psychiatry, La Fe University and Polytechnic Hospital, Valencia, Spain
*
*Corresponding author.

Abstract

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Introduction

Depression is the disease with the greatest burden of disability. Despite pharmacological options, up to 30% of depressions are considered resistant to treatment (RTD). Theta burst transcranial magnetic stimulation (TBS) on the dorsolateral prefrontal cortex allows the application of shorter protocols and with longer-lasting effects than conventional TMS. Its implementation in the Public Health System requires the design of efficient, cost-effective and accessible protocols for patients.

Objectives

The objective of this project is to assess the efficacy and safety of two intensive and spaced protocols (unilateral and bilateral) of 1800 pulses TBS compared to sham stimulation in outpatients with unipolar and bipolar TRD in a public hospital.

Methods

This project is the 1st double-blind placebo-controlled RCT with TBS in Spain. It is now in the recruitment phase. Patients receive a total of 22 sessions of 1800 pulses in 6 weeks: 5 days/week the 1st and 2nd weeks (10 sessions) and 3 sessions/week the following weeks (12 sessions). Patients are randomized into three groups: i) bilateral, ii) left unilateral, and iii) sham. The main variable is the change in the HDRS-17 score at the end of treatment compared to baseline. The results were analyzed with a general linear model of HDRS, using time as the intrasubject factor and randomization group as the intersubject factor, using resistance to treatment (Maudsley Score) and diagnosis (bipolar, unipolar) as covariates.

Results

Preliminary results from 13 participants (nbil=4, nuni=4, nsham=5) reveal a significant effect of (group x time) on HDRS change (p= 0.020) with no influence of Maudsley Score or diagnosis. The bilateral group presented a greater decrease in the HDRS with a mean difference of 4,38 points [CI95% 0,17-8,58), (p=0.043)] with respect to the unilateral group and a difference of 8.23 [CI95% 4,24-12,21)(p =0.001)] compared to the sham group.Table 1:Sample description. Data shown are means and standar deviations. In bold significant diferences p<0,05.

Bilateral TBS(n=4)UnilateralTBS(n=4)ShamTBS(n=5)
Age [M (SD)]55,50(5,80)48,50(16,86)56,40(5,86)
Male: Female [n]0:42:23:2
Depression:Bipolar disorder [n]3:13:14:1
Length of depresive episode (months) [M (SD)]12,00(4,08)16,50(6,61)15,00(5,83)
Current number of antidepressants [M (SD)]2,00(0,82)1,75(0,50)2,60(0,55)
Maudsley score [M (SD)]7,00(1,82)8,75(1,5)7,90(1,30)
Basal HDRS basal [M (SD)]16,00(1,82)19,75(4,03)20,40(3,21)
Final HDRS [M (SD)]5,75(3,30)10,75(3,10)17,80(2,49)
Response /Remission[n (%)]3:3 (75%)2:0(50:0%)0:0 (0%)

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Conclusions

The results demonstrate the preliminary efficacy of intensive TBS protocols relative to sham.

Disclosure of Interest

None Declared

Type
Abstract
Information
European Psychiatry , Volume 66 , Special Issue S1: Abstracts of the 31st European Congress of Psychiatry , March 2023 , pp. S608 - S609
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2023. Published by Cambridge University Press on behalf of the European Psychiatric Association
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