Superolateral medial forebrain bundle deep brain stimulation in major depression: a gateway trial

Coenen, Volker A.; Bewernick, Bettina H.; Kayser, Sarah; Kilian, Hannah; Boström, Jan; Greschus, Susanne; Hurlemann, René; Klein, Margaretha; Spanier, Susanne; Sajonz, Bastian; Urbach, Horst; Schläepfer, Thomas E.

doi:10.1038/s41386-019-0369-9

Cited by 133 publications

(127 citation statements)

References 43 publications

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“…Within individual DBS trials, no association has been shown between length of current episode and treatment response. Mean episode durations in published trials range from 3 to 12 years [7,12,14,15,18]. However, it is notable that in the BROADEN trial, a large industry sponsored RCT of SCC DBS, duration of current episode was around 12 years [11], nearly twice that of previous studies of SCC DBS in TRD [7,12,24].…”

Section: Duration Of Current Depressive Episodementioning

confidence: 98%

“…Naturally, as DBS is an invasive and investigative therapy in TRD, patients who undergo DBS implantation are very highly treatment-resistant. Methods of reporting medication trials and adequacy of such trials vary among studies, but mean medication trials in TRD DBS studies are generally in the range of 6-9 in the current episode [7,14,18], or 8-20 lifetime medication trials [11,14,15,18]. In contrast, the mean number of medication failures in rTMS RCTs for depression generally ranges from 1 to 3 [21].…”

Section: Degree Of Treatment Resistance/responsivenessmentioning

confidence: 99%

“…The subcallosal cingulate (SCC) is the most common stimulation site [2,[5][6][7][8][9][10][11][12]. Other stimulation sites include the ventral capsule/ventral striatum (VC/VS) [13,14], the anterior limb of the internal capsule (ALIC; adjacent to VC/VS) [15], and the superolateral branch of the median forebrain bundle (slMFB) [16][17][18]. Randomized controlled trials, with various study designs, have been conducted for DBS to the SCC (BROADEN) [11], VC/VS (RECLAIM) [14], and ALIC, [15]; plans exist for an RCT of DBS to the slMFB [18].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Deep brain stimulation for treatment-resistant depression: Predicting response and optimizing treatment

Conroy

Holtzheimer

2019

Personalized Medicine in Psychiatry

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Section: Duration Of Current Depressive Episodementioning

confidence: 98%

Section: Degree Of Treatment Resistance/responsivenessmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Deep brain stimulation for treatment-resistant depression: Predicting response and optimizing treatment

Conroy

Holtzheimer

2019

Personalized Medicine in Psychiatry

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“…In a sham‐controlled trial of MFB DBS, patients were randomly assigned to 8 weeks of MFB DBS or sham, after which all patients received active DBS. There were no group differences in active vs. sham DBS in the first 8 weeks; however, all patients improved with longer‐term DBS, with 50% of patients classified as remitters after 1 year of stimulation.…”

Section: Controlled Studiesmentioning

confidence: 99%

“…used a longer assessment period and showed higher response rates. Similarly, Coenen et al . showed a remission rate of 50% after 12 months.…”

Section: Future Studiesmentioning

confidence: 99%

Deep Brain Stimulation for Depression: Optimism for Continued Investigation

Rooij

Holtzheimer

2019

Clin Pharma and Therapeutics

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Magnitude of the Placebo Response Across Treatment Modalities Used for Treatment-Resistant Depression in Adults

et al. 2021

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IMPORTANCEThe placebo effect in depression clinical trials is a substantial factor associated with failure to establish efficacy of novel and repurposed treatments. However, the magnitude of the placebo effect and whether it differs across treatment modalities in treatment-resistant depression (TRD) is unclear.OBJECTIVE To examine the magnitude of the placebo effect in patients with TRD across different treatment modalities and its possible moderators. DATA SOURCESSearches were conducted on MEDLINE, Web of Science, and PsychInfo from inception to June 21, 2021. STUDY SELECTION Randomized clinical trials (RCTs) were included if they recruited patients with TRD and randomized them to a placebo or sham arm and a pharmacotherapy, brain stimulation, or psychotherapy arm. DATA EXTRACTION AND SYNTHESIS Independent reviewers used standard forms for data extraction and quality assessment. Random-effects analyses and standard pairwise meta-analyses were performed. MAIN OUTCOMES AND MEASURES The primary outcome was the Hedges g value for the reported depression scales. Secondary outcomes included moderators assessed via meta-regression and response and remission rates. Heterogeneity was assessed with the I 2 test, and publication bias was evaluated using the Egger test and a funnel plot. Cochrane Risk of Bias Tool was used to estimate risks. RESULTS Fifty RCTs were included involving various types of placebo or sham interventions with a total of 3228 participants (mean [SD] age, 45.8 [6.0] years; 1769 [54.8%] female). The pooledplacebo effect size for all modalities was large (g = 1.05; 95% CI, 0.91-1.1); the placebo effect size in RCTs of specific treatment modalities did not significantly differ. Similarly, response and remission rates associated with placebo were comparable across modalities. Heterogeneity was large. Three variables were associated with a larger placebo effect size: open-label prospective treatment before double-blind placebo randomization (β = 0.35; 95% CI, 0.11 to 0.59; P = .004), later year of publication (β = 0.03; 95% CI, 0.003 to 0.05; P = .03), and industry-sponsored trials (β = 0.34; 95% CI, 0.09 to 0.58; P = .007). The number of failed interventions was associated with the probability a smaller placebo effect size (β = −0.12; 95% CI, −0.23 to −0.01, P = .03). The Egger test result was not significant for small studies' effects. (continued) Key Points Question What is the placebo effect magnitude in different treatment modalities used for management of patients with treatment-resistant depression? Findings In this systematic review and meta-analysis of 3228 patients with treatment-resistant depression in 50 randomized clinical trials, the placebo effect size was large and consistent across treatment modalities. Response and remission rates associated with placebo effect were comparable across modalities.Meaning The findings of this study suggest a placebo effect size benchmark may be used to interpret the findings of past and future clinical trials.

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Superolateral medial forebrain bundle deep brain stimulation in major depression: a gateway trial

Cited by 133 publications

References 43 publications

Deep brain stimulation for treatment-resistant depression: Predicting response and optimizing treatment

Deep brain stimulation for treatment-resistant depression: Predicting response and optimizing treatment

Deep Brain Stimulation for Depression: Optimism for Continued Investigation

Magnitude of the Placebo Response Across Treatment Modalities Used for Treatment-Resistant Depression in Adults

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