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

ConditionsMajor Depression Anhedonia Melancholic Depression Theta Burst Stimulation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

SponsorGuo Wenbin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Left DLPFC + OFC iTBS
Device
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 iTBS
Device
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Left DLPFC + OFC iTBS GroupExperimental treatment 1 intervention

Group B: Left DLPFC iTBS GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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.

Other outcomes

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guo Wenbin

Lead sponsor

Central South University

Sponsor institution

Source ClinicalTrials.gov

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