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

8 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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?

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Hunan
      • Changsha, Hunan, Chine, 410000
        • Recrutement
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Meiqi Yan, Master
          • Numéro de téléphone: +86 18155517736
          • E-mail: meiqi7012@163.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Autres noms:
  • stimulation thêta-burst intermittente (iTBS)
Expérimental: 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.
Dispositif: 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.
Autres noms:
  • stimulation intermittente par rafale thêta

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Total score of Montgomery-Åsberg Depression Rating Scale (MADRS)
Délai: *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
Délai: * 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
Délai: * 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Total score of the Temporal Experience of Pleasure Scale - Chinese Version (TEPS-C)
Délai: *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
Délai: *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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
Délai: *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
Délai: *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
Délai: *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
Délai: *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)
Délai: *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
Délai: *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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Guo Wenbin

Les enquêteurs

  • Chercheur principal: Wenbin Guo, PhD, Second Xiangya Hospital of Central South University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 mai 2026

Achèvement primaire (Estimé)

3 juillet 2027

Achèvement de l'étude (Estimé)

3 juillet 2027

Dates d'inscription aux études

Première soumission

24 mai 2026

Première soumission répondant aux critères de contrôle qualité

8 septembre 2026

Première publication (Réel)

10 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • LYG20260013
  • ChiCTR2600125718 (Identificateur de registre: Chinese Clinical Trial Registry)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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