Efficacy and Mechanism of IPSRT for Bipolar II Disorder
12 juin 2026 mis à jour par: First Affiliated Hospital of Zhejiang University
The Efficacy and Mechanism of Different Intervention Strategy for Bipolar II Disorder Patients With Rhythm Disturbance
This project is based on the biphasic instability model and social timing theory, utilizing IPSRT to help regulate social interactions and establish regular daily habits, alleviate emotional symptoms, and prevent.
The included patients with bipolar II disorder who did not take medication for the first time or relapsed within the past month were randomly divided into a medication only group (Q group), a only IPSRT group (I group).
Group Q received treatment with quetiapine alone (starting at 50mg/day, with an additional 50mg to 300mg/day per week, and the dosage can be flexibly adjusted); Group I received 12 weeks of interpersonal and social rhythm therapy (12 sessions, once a week, 40 minutes each time, with relatively fixed tasks and agendas for each meeting).
Compare the changes in various clinical evaluation scales and skin potential before and after treatment, explore the safety and effectiveness of drug therapy and psychotherapy for patients with bipolar II disorder with rhythm disorders, and investigate the potential biological mechanism of IPSRT by collecting data on salivary cortisol and melatonin, peripheral circadian rhythm genes (PER1/PER2/PER3/BMAL1), and magnetic resonance.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
216
Phase
- Phase 2
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
- Nom: Huang Manli, Professor
- Numéro de téléphone: 13957162975 Ext. 86
- E-mail: huangmanli@zju.edu.cn
Lieux d'étude
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310000
- The First Affiliated Hospital of Zhejiang University
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Contact:
- Huang Manli, M.D
- Numéro de téléphone: 13957162975 Ext. 86
- E-mail: huangmanli@zju.edu.cn
-
-
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: a primary diagnosis of bipolar II disorder in accordance with DSM-V criteria, in a current major depressive episode;
2: scoring ≥17 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)
3: scoring <12 on the Young Mania Rating Scale (YMRS)
4: medication-free (≥4 weeks without psychotropics)
5: with rhythm disturbance, scoring >26 on the Biological Rhythm Interview for Neuropsychiatry (BRIAN)
6: Understand written language and be able to conduct questionnaire survey
7: 18 to 60 years old, gender is not limited
8: the patient voluntarily participates, signs a written informed consent form, is willing to participate in the study and undergo evaluation
9: Han Chinese
10: Right-handedness
Exclusion Criteria:
1: diseases that may significantly increase research risks or interfere with the evaluation of results
2: patients with rapid-cycling bipolar disorder (with >4 episodes within the past year);
3: any psychiatric or organic mental disorder, bipolar I disorder (BD I), current alcohol or drug dependence, borderline or antisocial personality disorder
4: patients currently receiving any psychological treatment or melatonin treatment intervention
5: patients with active suicidal ideation, HAMD-17 item 3 score ≥3
6: pregnant
7: patients with metal objects in the body (pacemaker, cochlear implant, implanted teeth, braces, metal foreign bodies, cardiac stent/intravascular coil, orthopedic steel plate, etc.) and other MRI examination contraindications (claustrophobia or inability to cooperate with the examination).
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: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Group Q
Patients received treatment with quetiapine alone (starting at 50mg/day, with an additional 50mg to 300mg/day per week, and the dosage can be flexibly adjusted)
|
Patients received treatment with quetiapine alone (starting at 50mg/day, with an additional 50mg to 300mg/day per week, and the dosage can be flexibly adjusted)
|
|
Expérimental: Group I
Patients received 12 weeks of interpersonal and social rhythm therapy (12 sessions, once a week, 40 minutes each time, with relatively fixed tasks and agendas for each meeting)
|
Patients received 12 weeks of interpersonal and social rhythm therapy (12 sessions, once a week, 40 minutes each time, with relatively fixed tasks and agendas for each meeting)
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hamilton Depression Scale (17-items) Total Score Change
Délai: Baseline，4，8，12 weeks after treatment
|
The Hamilton Depression Scale (17-items), is a 17 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
It's considered the gold standard for rating depression severity and used frequently in clinical trials.
Higher HAM-D17 score indicates more severe depression.
A reduction of 50% or more in total score from Baseline indicates clinical response.
|
Baseline，4，8，12 weeks after treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score
Délai: Baseline，4，8，12 weeks after treatment
|
The BRIAN comprises 18 items, which are divided in 3 areas: sleep and social rhythms, activities and eating pattern.
The total score ranged from 18 to 72, a higher score suggested a more severe biological rhythm disturbance.
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Baseline，4，8，12 weeks after treatment
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Neuroimaging
Délai: Baseline，12 weeks after treatment
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MRI
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Baseline，12 weeks after treatment
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Skin potential
Délai: Baseline，12 weeks after treatment
|
In a quiet environment, the subject's left hand was pre connected to a portable skin potential acquisition device to collect skin potential signals under different types of emotional stimulation task paradigms.
After denoising, 10 time-domain eigenvalues and 8 time-frequency domain eigenvalues were obtained for each task.
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Baseline，12 weeks after treatment
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Polysomnography
Délai: Baseline，12 weeks after treatment
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overnight polysomnography
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Baseline，12 weeks after treatment
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Change of the Brief Social Rhythm Scale (BSRS) score
Délai: Baseline，4，8，12 weeks after treatment
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The BSRS assess the irregularity with which participants engage in basic daily activities during the workweek and on the weekend, using a scale ranging from 1 (very regularly) to 6 (very irregularly）
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Baseline，4，8，12 weeks after treatment
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Neuropsychological tests
Délai: Baseline，12 weeks after treatment
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Software testing (Prisoner's Dilemma game, Social searching task)
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Baseline，12 weeks after treatment
|
|
Change of Beck Scale of Suicidal Ideation score
Délai: Baseline，4，8，12 weeks after treatment
|
Beck Scale of Suicidal Ideation is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week.
The BSI score ranges from 0 to 63, with higher scores indicating worse outcomes and lower scores indicating better outcomes.
|
Baseline，4，8，12 weeks after treatment
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Change of the Pittsburgh Sleep Quality Index (PSQI) score
Délai: Baseline，4，8，12 weeks after treatment
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The PSQI is a validated self-report questionnaire assessing sleep quality and disturbance over 1 month, quantifying 7 sleep-related domains, with higher scores indicating worse sleep quality.
|
Baseline，4，8，12 weeks after treatment
|
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Change of the Young Mania Rating Scale (YMRS) score
Délai: Baseline，4，8，12 weeks after treatment
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The Young Mania Rating Scale (YMRS) , is a 11 item diagnostic questionnaire used to measure the severity of mania symptom in patients with mood disorders.
|
Baseline，4，8，12 weeks after treatment
|
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Change of Hamilton Anxiety Scale score
Délai: Baseline，4，8，12 weeks after treatment
|
Hamilton Anxiety Scale is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients.
Each item on the scale is rated on a 5-point scale from 0 (not present) to 4 (severe), with the total score ranging from 0 to 68.
The HAMA-17 is often used in clinical and research settings to assess the severity of anxiety symptoms and to evaluate the effectiveness of treatments for anxiety.
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Baseline，4，8，12 weeks after treatment
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Change of the Sociaty Adaptive Scale score
Délai: Baseline，4，8，12 weeks after treatment
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SAS is a self-rating scale used to assess an individual's social functioning in areas such as work, study, interpersonal communication, and family life.
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Baseline，4，8，12 weeks after treatment
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blood
Délai: Baseline，12 weeks after treatment
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Blood samples are collected to analyze the expression levels of peripheral circadian clock genes (PER1/PER2/PER3/BMAL1).
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Baseline，12 weeks after treatment
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saliva samples
Délai: Baseline，12 weeks after treatment
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Saliva is employed for the analysis of cortisol and melatonin
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Baseline，12 weeks after treatment
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
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 (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
1 juillet 2029
Achèvement de l'étude (Estimé)
1 juillet 2029
Dates d'inscription aux études
Première soumission
12 juin 2026
Première soumission répondant aux critères de contrôle qualité
12 juin 2026
Première publication (Réel)
17 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles bipolaires et apparentés
- Les troubles mentaux
- Troubles de l'humeur
- Trouble bipolaire
- Composés de soufre
- Produits chimiques organiques
- Composés hétérocycliques
- Composés hétérocycliques, anneau fusionné
- Composés hétérocycliques, 3 ring
- Dibenzothiazépines
- Thiazépines
- Thiepins
- Fumarate de quétiapine
- Préparations pharmaceutiques
Autres numéros d'identification d'étude
- IIT20250074C-R2
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
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 .