An interventional study of Left DLPFC + OFC iTBS and Left DLPFC iTBS in Major Depression, Anhedonia and Melancholic Depression, sponsored by Guo Wenbin. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Guo Wenbin · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if the proposed intermittent theta burst stimulation (iTBS) protocol can effectively improve anhedonia symptoms in depressed patients. The stimulation targets in our protocol include (1) dual-target stimulation at the left dorsolateral prefrontal cortex (DLPFC) and orbitofrontal cortex (OFC). (2) single-target stimulation at the left DLPFC.
The main questions it aims to answer are:
Participants will:
Anhedonia, defined as the diminished capacity to experience pleasure, is a core symptom of Major Depressive Disorder (MDD). Patients with anhedonia exhibit a pervasive loss of interest or pleasure in all or almost all previously enjoyable activities, which frequently leads to a profound reduction in the desire to engage in rewarding behaviors. Previous studies have reported that anhedonia occurs in 37% to 72% of depressed individuals. Patients with depression accompanied by anhedonia tend to respond poorly to medication and psychotherapy but show relatively better responses to conventional physical treatments such as electroconvulsive therapy (ECT). Research has shown that improving anhedonia significantly enhances social functioning in depressed patients. Therefore, more effective treatments targeting anhedonia are needed. Achieving breakthroughs in therapeutic approaches and understanding their underlying mechanisms will contribute substantially to progress in this field.
Theta-burst stimulation (TBS) utilizes a stimulation pattern that closely mimics the natural firing frequencies of cerebral neurons. Accumulating evidence has demonstrated the clinical efficacy of intermittent TBS (iTBS) in alleviating depressive symptoms. Thus, this study aims to investigate and evaluate whether the proposed iTBS protocol can effectively improve anhedonia symptoms in depressed patients by regulating functional abnormalities.
The stimulation targets in our protocol include (1) dual-target stimulation at the left dorsolateral prefrontal cortex (DLPFC) and orbitofrontal cortex (OFC). (2) single-target stimulation at the left DLPFC.
The main questions it aims to answer are:
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 60 is below the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →This is the only study on the registry with Guo Wenbin as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
iTBS Parameter Specifications: 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. The total duration of a single session is 10 minutes, comprising 60 trains and yielding a total of 1,800 pulses per session. Treatment Protocol for Left DLPFC+OFC iTBS Group: Stimulations are first delivered to the left DLPFC-NAc functional region using the specified iTBS parameters (1,800 pulses per session), performed 3 sessions daily with a 50-minute interval between sessions. Subsequently, stimulation was applied to the left OFC-sgACC functional region with the identical parameters (1,800 pulses per session), also performed 3 sessions daily with a 50-minute interval. This yields a cumulative total of 10,800 pulses over 5 consecutive days, for a total of 54,000 pulses.
Device: Left DLPFC + OFC iTBS
iTBS Parameter Specifications: 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. The total duration of a single session is 10 minutes, comprising 60 trains and yielding a total of 1,800 pulses per session. Treatment Protocol for Left DLPFC iTBS Group: For Group B, stimulations are delivered solely to the left DLPFC-NAc functional region using the specified iTBS parameters, performed 6 sessions daily with a 50-minute interval between sessions. This yields a cumulative total of 10,800 pulses over 5 consecutive days, for a total of 54,000 pulses.
Device: Left DLPFC iTBS
iTBS Parameter Specifications: 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. The total duration of a single session is 10 minutes, comprising 60 trains and yielding a total of 1,800 pulses per session. For the Left DLPFC + OFC iTBS Group, stimulation is first delivered to the left DLPFC-NAc functional region using the specified iTBS parameters (1,800 pulses per session), performed 3 sessions daily with a 50-minute interval between sessions. Subsequently, stimulation is applied to the left OFC-sgACC functional region with the identical parameters (1,800 pulses per session), also performed 3 sessions daily with a 50-minute interval. This yields a cumulative total of 10,800 pulses over 5 consecutive days, for a total of 54,000 pulses.
Also known as: intermittent theta-burst stimulation (iTBS)
iTBS Parameter Specifications: 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. The total duration of a single session is 10 minutes, comprising 60 trains and yielding a total of 1,800 pulses per session. For the left DLPFC iTBS Group, stimulation is delivered solely to the left DLPFC-NAc functional region using the specified iTBS parameters, with 6 sessions performed daily, each with a 50-minute interval between sessions. This yields a cumulative total of 10,800 pulses over 5 consecutive days, for a total of 54,000 pulses.
Also known as: intermittent theta burst stimulation
Total score of Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (MADRS) scores will be evaluated before and after treatment. Total score: 0-60. A higher score means worse depressive symptoms.
Time frame: *Baseline; * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Remission Rate of Montgomery-Åsberg Depression Rating Scale (MADRS) scores
The proportion of patients in each group achieving remission. Remission is defined as a MADRS score \< 11 points.
Time frame: * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Response Rate of Montgomery-Åsberg Depression Rating Scale (MADRS) scores
The percentage change in MADRS scores from baseline, calculated as \[(MADRSpre - MADRSpost) / MADRSpre\] \* 100%.
Time frame: * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Total score of the Temporal Experience of Pleasure Scale - Chinese Version (TEPS-C)
Total score: 20-120. The lower score means worse anhedonia.
Time frame: *Baseline; *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Remission rate of Temporal Experience of Pleasure Scale - Chinese Version (TEPS-C) score
Remission means the TEPS-C score \> 76. The TEPS-C remission rate is the proportion of patients in each group whose TEPS-C scores increased to \>76 after treatment.
Time frame: *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
Total score: 0-52. A higher score means worse depressive symptoms.
Time frame: *Baseline; *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Total scores of the Chinese version of the Snaith-Hamilton Pleasure Scale (SHAPS-C) score
Total score: 14-56. A higher score means worse anhedonia.
Time frame: *Baseline; *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Brain MRI
Resting-state magnetic resonance imaging scans will be conducted. Resting-state functional connectivity (rs-FC) changes before and after treatment will be assessed by fMRI. And its potential correlation with clinical symptom changes will be further explored.
Time frame: *Baseline; *Day 6, up to 1day delay; *8 weeks post-treatment.
Questionnaire: The Beck Scale for Suicide Ideation (BSI) scores
The Beck Scale for Suicide Ideation (BSI) scores will be evaluated before and after treatment. Total score: 0-38. Higher scores indicate greater severity of suicidal ideation.
Time frame: *Baseline; *Day 6; * 1 week post-treatment; * 4 weeks post-treatment; * 8 weeks post-treatment.
Total Score of the Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)
The RBANS is an instrument used to assess cognitive functioning. The Total Scale Score will be evaluated. The standard score range is typically 40 to 160 (index score based). A higher score indicates better cognitive performance.
Time frame: *Baseline; *Day 6; * 8 weeks post-treatment.
Wisconsin Card Sorting Test (WCST) Perseverative Errors scores
The WCST is an assessment of executive function and cognitive flexibility. This measure evaluates the number of perseverative errors, which occur when a participant continues to apply a previous sorting rule after the rule has changed. For this 48-card version, the theoretical score ranges from 0 to 48. A higher score indicates worse cognitive flexibility and greater executive dysfunction.
Time frame: *Baseline; *Day 6; *8 weeks post-treatment.
Plan to share: No — Individual participant data will not be shared to ensure strict confidentiality and protect participant privacy.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.