Trial reportJournal of psychiatry & neuroscience : JPN2015
A randomized double-blind crossover trial of deep brain stimulation of the subcallosal cingulate gyrus in patients with treatment-resistant depression: a pilot study of relapse prevention.
Trial report in Journal of psychiatry & neuroscience : JPN, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
DEEP BRAIN STIMULATION IN TREATMENT RESISTANT MAJOR DEPRESSION. Controlled and Crossed Study on Efficacy and Safety.
A Clinical Pilot Study Examining Bilateral Inhibition of the Lateral Habenula as a Target for Deep Brain Stimulation in Intractable Depression
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Neuromodulation Treatments of Pathological Anxiety in Anxiety Disorders, Stressor-Related Disorders, and Major Depressive Disorder: A Dimensional Systematic Review and Meta-Analysis.Frontiers in psychiatry · 2022Pooled it
- Deep Brain Stimulation in Treatment-Resistant Depression: A Systematic Review and Meta-Analysis on Efficacy and Safety.Frontiers in neuroscience · 2021Pooled it
- Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 4. Neurostimulation Treatments.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2016Pooled it
- Lack of neuropsychological effects following short-term subcallosal cingulate gyrus deep brain stimulation in treatment-resistant depression: a randomised crossover study.BMJ mental health · 2025Trial
- Deep brain stimulation in treatment resistant schizophrenia: A pilot randomized cross-over clinical trial.EBioMedicine · 2020Trial
- Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.NeuroImage. Clinical · 2020Trial
- The Targets of Deep Brain Stimulation in the Treatment of Treatment-Resistant Depression: A Review.Brain and behavior · 2025Review
- Deep brain stimulation for refractory major depressive disorder: a comprehensive review.Molecular psychiatry · 2024Review
- Deep Brain Stimulation (DBS) in Treatment-Resistant Depression (TRD): Hope and Concern.Advances in experimental medicine and biology · 2024Review
- Serotonin 5-HTPsychopharmacology · 2022Article
- Deep Brain Stimulation for Depression.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022Review
- Article
- Biomarkers for Deep Brain Stimulation in Animal Models of Depression.Neuromodulation : journal of the International Neuromodulation Society · 2022Review
- White Matter Tracts Associated With Deep Brain Stimulation Targets in Major Depressive Disorder: A Systematic Review.Frontiers in psychiatry · 2022Review
- Deep brain stimulation of the "medial forebrain bundle": a strategy to modulate the reward system and manage treatment-resistant depression.Molecular psychiatry · 2022Review
- Variability of white matter anatomy in the subcallosal cingulate area.Human brain mapping · 2021Article
- Deep brain stimulation for psychiatric disorders: From focal brain targets to cognitive networks.NeuroImage · 2021Review
- Recruitment Challenges for Studies of Deep Brain Stimulation for Treatment-Resistant Depression.Neuropsychiatric disease and treatment · 2021Article
- A New Viewpoint on the Etiopathogenesis of Depression: Insights From the Neurophysiology of Deep Brain Stimulation in Parkinson's Disease and Treatment-Resistant Depression.Frontiers in psychiatry · 2021Article
- Women in Neuromodulation: Innovative Contributions to Stereotactic and Functional Neurosurgery.Frontiers in human neuroscience · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo date, antidepressant drugs show limited efficacy, leaving a large number of patients experiencing severe and persistent symptoms of major depression. Previous open-label clinical trials have reported significant sustained improvements with deep brain stimulation (DBS) of the subcallosal cingulate gyrus (SCG) in patients with severe, chronic treatment-resistant depression (TRD). This study aimed to confirm the efficacy and measure the impact of discontinuation of the electrical stimulation.
methodsWe conducted a 6-month double-blind, randomized, sham-controlled crossover study in implanted patients with previous severe TRD who experienced full remission after chronic stimulation. After more than 3 months of stable remission, patients were randomly assigned to 2 treatment arms: the ON-OFF arm, which involved active electrode stimulation for 3 months followed by sham stimulation for 3 months, and the OFF-ON arm, which involved sham stimulation for 3 months followed by active stimulation for 3 months. The primary outcome measure was the difference in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score between sham and active stimulation.
resultsWe enrolled 5 patients in our trial. A Friedman repeated-measures analysis of variance revealed a significant effect of treatment (χ(2)1 = 5.0, p = 0.025) in patients with higher depression scores during sham stimulation. At the end of active stimulation, depression was remitted in 4 of 5 patients and none of them had experienced a relapse, whereas at the end of sham stimulation, 2 patients remained in remission, 2 relapsed and 1 showed a progressive worsening without reaching relapse criteria. LIMITATIONS: The small sample size limited the statistical power and external validity.
conclusionThese preliminary findings indicate that DBS of the SCG is an effective and safe treatment for severe forms of TRD and that continuous electrical stimulation is required to maintain therapeutic effects.
trial registrationNCT01268137 (ClinicalTrials.gov).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.