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

2026년 9월 8일 업데이트: Guo Wenbin

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:

  • 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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?

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Hunan
      • Changsha, Hunan, 중국, 410000
        • 모병
        • The Second Xiangya Hospital of Central South University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Left DLPFC + OFC iTBS Group

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.
장치: 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.
다른 이름들:
  • 간헐적 세타 버스트 자극(iTBS)
실험적: Left DLPFC iTBS Group

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.
장치: 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.
다른 이름들:
  • 간헐적 세타 버스트 자극

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Total score of Montgomery-Åsberg Depression Rating Scale (MADRS)
기간: *Baseline; * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
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.
*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
기간: * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
The proportion of patients in each group achieving remission. Remission is defined as a MADRS score < 11 points.
* 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
기간: * Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
The percentage change in MADRS scores from baseline, calculated as [(MADRSpre - MADRSpost) / MADRSpre] * 100%.
* Day 2- Day 6 (every treatment day); *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.

2차 결과 측정

결과 측정
측정값 설명
기간
Total score of the Temporal Experience of Pleasure Scale - Chinese Version (TEPS-C)
기간: *Baseline; *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Total score: 20-120. The lower score means worse anhedonia.
*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
기간: *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
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.
*Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.

기타 결과 측정

결과 측정
측정값 설명
기간
Total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
기간: *Baseline; *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Total score: 0-52. A higher score means worse depressive symptoms.
*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
기간: *Baseline; *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Total score: 14-56. A higher score means worse anhedonia.
*Baseline; *Day 6; *1 week post-treatment; *4 weeks post-treatment; *8 weeks post-treatment.
Brain MRI
기간: *Baseline; *Day 6, up to 1day delay; *8 weeks post-treatment.
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.
*Baseline; *Day 6, up to 1day delay; *8 weeks post-treatment.
Questionnaire: The Beck Scale for Suicide Ideation (BSI) scores
기간: *Baseline; *Day 6; * 1 week post-treatment; * 4 weeks post-treatment; * 8 weeks post-treatment.
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.
*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)
기간: *Baseline; *Day 6; * 8 weeks post-treatment.
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.
*Baseline; *Day 6; * 8 weeks post-treatment.
Wisconsin Card Sorting Test (WCST) Perseverative Errors scores
기간: *Baseline; *Day 6; *8 weeks post-treatment.
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.
*Baseline; *Day 6; *8 weeks post-treatment.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Guo Wenbin

수사관

  • 수석 연구원: Wenbin Guo, PhD, Second Xiangya Hospital of Central South University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 19일

기본 완료 (추정된)

2027년 7월 3일

연구 완료 (추정된)

2027년 7월 3일

연구 등록 날짜

최초 제출

2026년 5월 24일

QC 기준을 충족하는 최초 제출

2026년 9월 8일

처음 게시됨 (실제)

2026년 9월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 8일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • LYG20260013
  • ChiCTR2600125718 (레지스트리 식별자: Chinese Clinical Trial Registry)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared to ensure strict confidentiality and protect participant privacy.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다