Recruiting

Study on iTBS Regulating the Reward Circuit Function to Improve Anhedonia in Depression

ClinicalTrials.gov IDNCT07813169

PhaseNA

Enrollment60

SponsorGuo Wenbin

Age18 Years

SexALL

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Conditions studied

Major Depression, Anhedonia, Melancholic Depression, Theta Burst Stimulation

About this study

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: * Whether iTBS of dual-target stimulation (left DLPFC and OFC) can improve the symptoms of anhedonia and better than single-target stimulation at the left DLPFC? * Whether iTBS of the dual targets of left DLPFC and OFC can improve the symptoms of anhedonia by correcting the abnormal functional connectivity of DLPFC-NAc and OFC-sgACC, regulating the functional abnormalities of NAc and sgACC, and indirectly repairing the overall dysfunction of the reward circuit. * Researchers will compare dual-target stimulation to single-target stimulation and sham dual-target stimulation (a dedicated sham coil is utilized which produces an identical audible click and physical sensation) to see if the proposed iTBS protocol works to treat anhedonia. Participants will: * Take 6 sessions of dual-target iTBS or single-target iTBS every day, for 5 consecutive days. * Visit our hospital at 1 week, 4 weeks, and 8weeks after the iTBS treatment completion, for clinical evaluation and brain image examination.

Interventions

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. 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.
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 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.

Primary outcomes

Total score of Montgomery-Åsberg Depression Rating Scale (MADRS) (*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 (* 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 (* Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.)

Eligibility information

Inclusion Criteria: 1. Aged 18-45 years, and right-handed; 2. Diagnosed with major depressive disorder (MDD) by at least two qualified psychiatrists, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20 or a 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17; 3. Evaluated by a psychiatrist as having prominent anhedonia, and meeting the cutoff criteria on two self-report anhedonia scales, including a Snaith-Hamilton Pleasure Scale, Chinese version (SHAPS-C) score ≥ 20, or a Temporal Experience of Pleasure Scale, Chinese version (TEPS-C) score ≤ 76; 4. Medication type and dosage remained unchanged for at least 4 weeks prior to treatment initiation and throughout the study period; 5. MADRS item 10 score ≤ 4. Exclusion Criteria: 1. A history of epilepsy, seizures, stroke, or other serious organic brain diseases; 2. Presence of severe infectious diseases, malignant tumors, or other major unstable medical conditions; 3. Intellectual disability or developmental delay, presence of psychotic symptoms, or meeting the diagnostic criteria for other psychiatric disorders; 4. A history of substance abuse or psychoactive substance use; 5. Presence of intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes), or any other metallic objects in or near the head that cannot be safely removed (excluding dental fillings); 6. Contraindications to MRI or structural intracranial abnormalities detected on MRI; 7. Pregnant or breastfeeding women; 8. Receipt of electroconvulsive therapy (ECT) within the past 6 months, or transcranial magnetic stimulation (TMS) within the past 3 months; 9. Current daily use of lorazepam \> 2 mg (or an equivalent dose), or use of antiepileptic drugs at any dose; 10. Presence of strong suicidal ideation, or a MADRS item 10 score \> 4.

Study locations

The Second Xiangya Hospital of Central South University, Changsha, Hunan 410000 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.