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Major DepressioniTMMDDNCT07813169

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

A study testing Left DLPFC + OFC iTBS and Left DLPFC iTBS in people with Major Depression and Anhedonia, run by Guo Wenbin at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Left DLPFC + OFC iTBS and Left DLPFC iTBS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
19 May 2026to 3 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Aged 18-45 years, and right-handed;
  • 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;
  • 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;
  • Medication type and dosage remained unchanged for at least 4 weeks prior to treatment initiation and throughout the study period;
  • MADRS item 10 score ≤ 4.

Who cannot join

  • A history of epilepsy, seizures, stroke, or other serious organic brain diseases;
  • Presence of severe infectious diseases, malignant tumors, or other major unstable medical conditions;
  • Intellectual disability or developmental delay, presence of psychotic symptoms, or meeting the diagnostic criteria for other psychiatric disorders;
  • A history of substance abuse or psychoactive substance use;
  • 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);
  • Contraindications to MRI or structural intracranial abnormalities detected on MRI;
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  • Pregnant or breastfeeding women;
  • Receipt of electroconvulsive therapy (ECT) within the past 6 months, or transcranial magnetic stimulation (TMS) within the past 3 months;
  • Current daily use of lorazepam > 2 mg (or an equivalent dose), or use of antiepileptic drugs at any dose;
  • Presence of strong suicidal ideation, or a MADRS item 10 score > 4.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

    Meiqi Yan, Master, +86 18155517736, meiqi7012@163.com

    Recruiting

Other trials in China

About this study

Official title: Study on the Efficacy of iTBS Targeting NAc and sgACC in Regulating the Reward Circuit Function to Improve Anhedonia in Depression

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:

Read more
  • 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.
Read the detailed description

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:

  1. Whether iTBS of dual-target stimulation (left DLPFC and OFC) can improve the symptoms of anhedonia and better than single-target stimulation?
  2. Whether iTBS of the dual targets of left DLPFC and OFC can improve the anhedonia symptom 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?
Being tested
Left DLPFC + OFC iTBS, Left DLPFC iTBS
Medical subject headings
Depressive Disorder, Major, Anhedonia, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left DLPFC + OFC iTBSDevice

    Also called 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 + 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.

  • Left DLPFC iTBSDevice

    Also called intermittent theta burst stimulation

    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.

Study groups in NCT07813169
Study groupRoleWhat they receive
Left DLPFC + OFC iTBS GroupExperimentaliTBS 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.
Receives: Device: Left DLPFC + OFC iTBS
Left DLPFC iTBS GroupExperimentaliTBS 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.
Receives: Device: Left DLPFC iTBS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: *Baseline; * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.

  2. 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.

    Measured: * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.

  3. Response Rate of Montgomery-Åsberg Depression Rating Scale (MADRS) scores

    The percentage change in MADRS scores from baseline, calculated as [(MADRSpre - MADRSpost) / MADRSpre] * 100%.

    Measured: * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.

Secondary outcomes (2)
  1. Total score of the Temporal Experience of Pleasure Scale - Chinese Version (TEPS-C)

    Total score: 20-120. The lower score means worse anhedonia.

    Measured: *Baseline; *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.

  2. 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.

    Measured: *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start19 May 2026
  3. Primary completion3 Jul 2027 (estimated)
  4. Study completion3 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07813169
Sponsor's protocol ID
LYG20260013
Other IDs
ChiCTR2600125718
Acronym
iTMMDD
Status last verified
Sep 2026
First submitted
24 May 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to ensure strict confidentiality and protect participant privacy.

Questions about this trial

What is this clinical trial studying?

A study testing Left DLPFC + OFC iTBS and Left DLPFC iTBS in people with Major Depression and Anhedonia, run by Guo Wenbin at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenbin Guo, PhD (+86 73185360921, guowenbin76@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total score of Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: *Baseline; * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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