Adjunctive fast repetitive transcranial magnetic stimulation in depression

Anderson, Ian M.; Delvai, Nicola A; Ashim, Bettadapura; Ashim, Sindhu; Lewin, Cherry; Singh, Vipender; Sturman, D; Strickland, Paul

doi:10.1192/bjp.bp.106.028019

Cited by 45 publications

(40 citation statements)

References 9 publications

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“…We chose to look for articles after 2002 as Martin et al 's meta‐analysis () reviewed previous trials. The detailed literature search and selection criteria are described elsewhere (Brunoni et al , ); in summary, we searched for the keywords “depression”, “transcranial magnetic stimulation” and “sham” on MEDLINE, Web of Science, Cochrane and Scielo as to include only randomized, double‐blinded, sham‐controlled, parallel trials – 29 rTMS studies were found (Anderson et al , ; Avery et al , ; Bortolomasi et al , ; Boutros et al , ; Bretlau et al , ; Fitzgerald et al , ; Fitzgerald et al , ; Garcia‐Toro et al , ; Hausmann et al , ; Herwig et al , ; Herwig et al , ; Holtzheimer et al , ; Hoppner et al , ; Januel et al , ; Jorge et al , ; Jorge et al , ; Koerselman et al , ; Loo et al , ; Loo et al , ; Mogg et al , ; Mosimann et al , ; O'Reardon et al , ; Poulet et al , ; Rossini et al , , ; Rumi et al , ; Stern et al , ; Su et al , ). The same criteria were used for tDCS, identifying two additional studies (Boggio et al , ; Fregni et al , ), for a total of 31.…”

Section: Methodsmentioning

confidence: 99%

Clinical trial design in non-invasive brain stimulation psychiatric research

Brunoni

Fregni

2011

Int. J. Methods Psychiatr. Res.

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Major depressive disorder (MDD) trials - investigating either non-pharmacological or pharmacological interventions - have shown mixed results. Many reasons explain this heterogeneity, but one that stands out is the trial design due to specific challenges in the field. We aimed therefore to review the methodology of non-invasive brain stimulation (NIBS) trials and provide a framework to improve clinical trial design. We performed a systematic review for randomized, controlled MDD trials whose intervention was transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) in MEDLINE and other databases from April 2002 to April 2008. We created an unstructured checklist based on CONSORT guidelines to extract items such as power analysis, sham method, blinding assessment, allocation concealment, operational criteria used for MDD, definition of refractory depression and primary study hypotheses. Thirty-one studies were included. We found that the main methodological issues can be divided in to three groups: (1) issues related to phase II/small trials, (2) issues related to MDD trials and, (3) specific issues of NIBS studies. Taken together, they can threaten study validity and lead to inconclusive results. Feasible solutions include: estimating the sample size a priori; measuring the degree of refractoriness of the subjects; specifying the primary hypothesis and statistical tests; controlling predictor variables through stratification randomization methods or using strict eligibility criteria; adjusting the study design to the target population; using adaptive designs and exploring NIBS efficacy employing biological markers. In conclusion, our study summarizes the main methodological issues of NIBS trials and proposes a number of alternatives to manage them.

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Section: Methodsmentioning

confidence: 99%

Clinical trial design in non-invasive brain stimulation psychiatric research

Brunoni

Fregni

2011

Int. J. Methods Psychiatr. Res.

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“…For rTMS studies that used MADRS scores as the primary outcome, we used the values of HDRS scores reported in secondary outcomes when this was possible [26], [28], [29], [30], [31]; in four studies this was not possible [20], [32], [33], [34] and therefore we imputed missing HDRS scores regressing for other variables. Finally we assessed whether improvement in the active group was correlated with the placebo response – including this variable in our model.…”

Section: Methodsmentioning

confidence: 99%

Placebo Response of Non-Pharmacological and Pharmacological Trials in Major Depression: A Systematic Review and Meta-Analysis

et al. 2009

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BackgroundAlthough meta-analyses have shown that placebo responses are large in Major Depressive Disorder (MDD) trials; the placebo response of devices such as repetitive transcranial magnetic stimulation (rTMS) has not been systematically assessed. We proposed to assess placebo responses in two categories of MDD trials: pharmacological (antidepressant drugs) and non-pharmacological (device- rTMS) trials.Methodology/Principal FindingsWe performed a systematic review and meta-analysis of the literature from April 2002 to April 2008, searching MEDLINE, Cochrane, Scielo and CRISP electronic databases and reference lists from retrieved studies and conference abstracts. We used the keywords placebo and depression and escitalopram for pharmacological studies; and transcranial magnetic stimulation and depression and sham for non-pharmacological studies. All randomized, double-blinded, placebo-controlled, parallel articles on major depressive disorder were included. Forty-one studies met our inclusion criteria - 29 in the rTMS arm and 12 in the escitalopram arm. We extracted the mean and standard values of depression scores in the placebo group of each study. Then, we calculated the pooled effect size for escitalopram and rTMS arm separately, using Cohen's d as the measure of effect size. We found that placebo response are large for both escitalopram (Cohen's d - random-effects model - 1.48; 95%C.I. 1.26 to 1.6) and rTMS studies (0.82; 95%C.I. 0.63 to 1). Exploratory analyses show that sham response is associated with refractoriness and with the use of rTMS as an add-on therapy, but not with age, gender and sham method utilized.Conclusions/SignificanceWe confirmed that placebo response in MDD is large regardless of the intervention and is associated with depression refractoriness and treatment combination (add-on rTMS studies). The magnitude of the placebo response seems to be related with study population and study design rather than the intervention itself.

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“…Of N = 105 studies assessed in full‐length and listed in Supporting Information (Table S3), N = 18 studies met the following inclusion criteria for the current meta‐analysis: double‐blind, parallel‐design RCT with an inactive sham group and a follow‐up of any length during which maintenance rTMS was not administered; major depressive disorder or episode diagnosed according to DSM‐IV or ICD‐10 criteria; depression severity assessed using any version of a standardized scale: Hamilton Depression Rating Scale, HAMD, or Montgomery Åsberg Depression Rating Scale, MADRS; high‐frequency (>1 Hz) rTMS or sham administered to the left DLPFC. …”

Section: Methodsmentioning

confidence: 99%

“…Of N = 105 studies assessed in full-length and listed in Supporting Information (Table S3), N = 18 studies [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35] met the following inclusion criteria for the current meta-analysis:…”

Section: Systematic Literature Search and Study Selectionmentioning

confidence: 99%