An interventional study of Transcranial direct current stimulation (tDCS) on the Left DLPFC and Transcranial direct current stimulation (tDCS) on the right VLPFC in Major Depressive Disorder and Loneliness, sponsored by Guangzhou Psychiatric Hospital. Recruiting at 1 site in China. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Guangzhou Psychiatric Hospital · Not applicable, Interventional, and Treatment
Among 206 studies in Depressive Disorder, Major with a site in China — 74 open to participants now, 77 under way, 5 of them phase 3. Depressive Disorder, Major · China.
Among the 206 studies in Depressive Disorder, Major with a site in China, this one is the 62nd largest by planned enrollment of the 173 interventional ones, is one of 16 that started in 2024, is one of 99 with no phase, reaches primary completion later than 36 of the 76 other live ones, and was the 151st registered.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 180 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →74 of the 206 studies in Depressive Disorder, Major with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 410 Depressive Disorder, Major studies recruiting now, 92 (22%) set no upper age limit and 292 (71%) stop at 75 or younger; 54 take children under 18; 98 take healthy volunteers.
This study: 60 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →206 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 16 started in 2024.
Median enrollment 120 across the 173 interventional studies, 240 across the 33 observational. Of the 76 that completed or were terminated, 8 (11%) have results posted.
43 of 206 have an industry lead sponsor. The 10 most frequent:
Guangzhou Psychiatric Hospital is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Guangzhou Psychiatric Hospital has 5 studies filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
21 of the studies in Depressive Disorder, Major with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04984512Phase 3Sunshine Lake Pharma Co., Ltd.The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder | 2027-07 |
| NCT07282366Jian-Jun OuVideo Intervention to Reduce Depression-related Stigma Among Adolescents | 2026-11-20 |
| NCT06913309Peking University Sixth HospitalClinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder | 2026-11-30 |
| NCT06409325Shanghai Mental Health CenterEffectiveness of MST Versus ECT for Major Depressive Episode | 2026-12-30 |
| NCT07873060Qilu Hospital of Shandong UniversityComparing 10 Hz rTMS and iTBS for Adolescent Depression | 2026-12-31 |
Among the 206 studies in Depressive Disorder, Major with a site in China, from their registry updates:
High loneliness is prevalent among older adults and is a significant risk factor for major depression and low recovery rates in patients. Current interventions for loneliness are limited. Previous research has demonstrated a link between loneliness, negative social emotions, and reduced resting-state functional connectivity in the lateral prefrontal cortex (LPFC) and the default mode network (DMN). Transcranial direct current stimulation (tDCS) has shown promise in enhancing emotional regulation and connectivity, potentially alleviating loneliness in older adults with depression.
Loneliness is a pervasive issue among older adults, significantly increasing the risk of major depression and contributing to low recovery rates in affected individuals. Despite its widespread impact, current interventions aimed at alleviating loneliness remain limited and often ineffective. Research has revealed a strong connection between feelings of loneliness, negative social emotions, and decreased resting-state functional connectivity in key brain regions, particularly the lateral prefrontal cortex (LPFC) and the default mode network (DMN). These findings suggest that the neural underpinnings of loneliness may be targeted to improve emotional well-being.
Transcranial direct current stimulation (tDCS) emerges as a promising intervention in this context, as it has been shown to enhance emotional regulation and improve functional connectivity within these neural networks. By applying low electrical currents to specific brain areas, tDCS may help mitigate feelings of loneliness, thereby fostering a greater sense of social connection among older adults with depression.
Objectives Evaluate the Effects of Repeated tDCS on Loneliness Levels: This trial aims to systematically assess how repeated sessions of tDCS influence loneliness in older adults with major depressive disorder. By comparing these groups, we hope to understand the differential impacts of tDCS on loneliness, taking into account the potential confounding effects of depression.
Elucidate the Neuro-Emotional Mechanisms: A key objective is to uncover the neuro-emotional mechanisms that underlie the effects of tDCS on loneliness. This involves examining changes in neural activity and connectivity patterns in the LPFC and DMN, as well as tracking shifts in negative social emotions that may accompany improvements in loneliness. Understanding these mechanisms could enhance the efficacy of tDCS as an intervention.
Develop Predictive Models for Individualized Treatment Outcomes: Another important aim of this trial is to create predictive models that utilize neuro-emotional data to tailor treatment approaches for individuals. By identifying specific neural and emotional markers that correlate with positive outcomes from tDCS, we can move toward more personalized interventions, potentially improving recovery rates and overall mental health in older adults with depression facing loneliness.
This trial represents a significant step toward addressing the critical issue of loneliness in older adults with depression, with the potential to offer a novel and effective intervention strategy that integrates neurobiology and emotional health.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. Based on the EEG 10-20 international system, the positive electrode was placed at position F3, and the negative electrode was placed in the right supraorbital area/FP2 (e.g., Dubreuil-Vall et al., 2021, Biol Psychiatry: CNNI)
Device: Transcranial direct current stimulation (tDCS) on the Left DLPFC
The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. Based on the EEG 10-20 international system, the positive electrode for stimulating the right VLPFC was placed at position F6, while the negative electrode was placed in the left supraorbital area/FP1 (e.g., He et al., 2020, Psychol Med).
Device: Transcranial direct current stimulation (tDCS) on the right VLPFC
In the sham stimulation group, the electrode positions were randomized to match those of the rVLPFC or lDLPFC groups, but the stimulation only lasted for the first 30 seconds.
Device: Sham stimulation group
The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. For stimulating the lDLPFC, the positive electrode was placed at position F3, and the negative electrode was placed in the right supraorbital area/FP2 (e.g., Dubreuil-Vall et al., 2021, Biol Psychiatry: CNNI).
The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. Based on the EEG 10-20 international system, the positive electrode for stimulating the rVLPFC was placed at position F6, while the negative electrode was placed in the left supraorbital area/FP1 (e.g., He et al., 2020, Psychol Med)
The electrode positions were randomized to match those of the rVLPFC or lDLPFC groups, but the stimulation only lasted for the first 30 seconds.
Change in loneliness levels from baseline measured by the UCLA Loneliness Scale from baseline
This outcome measures the change in loneliness levels among participants, assessed using the UCLA Loneliness Scale. Evaluations will occur at baseline, 1 month, and 3 months post-intervention (after the two weeks of intervention, the same as below) to determine the effectiveness of the tDCS intervention on reducing feelings of loneliness in patients with depression.
Time frame: 2 weeks, 1.5 months and 3.5 months
Change in Emotional and Motivational Ratings from baseline
Participants' emotional and motivational responses will be assessed using a word rating task, which evaluates how different words or stimuli evoke emotional and motivational reactions.
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Social Participation Levels from baseline
The PM-3D4D questionnaire will be utilized to assess participants' levels of social participation, focusing on engagement in social activities and interactions.
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Social Motivation from baseline
Social motivation will be evaluated through the Social Motivation Questionnaire, which examines the intrinsic and extrinsic factors that drive social engagement in individuals.
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Social Network from baseline
The Lubben Social Network Scale will be used to assess participants' social networks
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Emotional Regulation from baseline
The Cognitive Emotion Regulation Questionnaire will be used to assess participants' emotion regulation functions.
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Affective Traits from baseline
Affective traits will be evaluated using the Chinese Affect Scale, which assess individual differences in emotional experiences and behavioral tendencies.
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Reward Sensitivity from baseline
The Temporal Experience of Pleasure Scale will be used to assess participants' reward sensitivity.
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Depressive Symptoms from baseline
Hamilton Depression Rating Scale (HAM-D) will be employed to measure the severity of depressive symptoms among participants, providing insight into their mental health status.
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Resting-State Functional Connectivity from baseline
Resting State Functional Connectivity among major brain networks based on T2-weighted functional magnetic resonance imaging data will be assessed.
Time frame: 2 weeks, 1.5 months and 3.5 months
Change in social support from baseline
the Multidimensional Scale of Perceived Social Support will be used to assess participants' perceived social support
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Emotion Coping from baseline
The COPE questionnaire will be used to assess participants' emotion coping under adversity.
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Incentive-Driven Behavioural Tendencies from baseline
The Behavioural Activation/Inhibition Scale will be used to assess participants' behavioural tendencies driven by rewards and punishments.
Time frame: 2 weeks, 1.5 months and 3.5 months
changes in Anhedonia level from baseline
The Dimensional Anhedonia Rating Scale will be used to assess participants' anhedonia level.
Time frame: 2 weeks, 1.5 months and 3.5 months
Plan to share: No
Start is estimated for Oct 2024; primary completion for Oct 2026, 23 months later.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 23 months is below that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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Guangzhou Psychiatric Hospital