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Efficacy and Mechanism of IPSRT for Bipolar II Disorder

12. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

216

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The First Affiliated Hospital of Zhejiang University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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)
Arzneimittel: Quetiapine (drug)
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)
Experimental: 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)
Verhalten: Psychopharmacological treatment
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)
Andere Namen:
  • Interpersonal and Social Rhythm Therapy (IPSRT)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hamilton Depression Scale (17-items) Total Score Change
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score
Zeitfenster: 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.
Baseline，4，8，12 weeks after treatment
Neuroimaging
Zeitfenster: Baseline，12 weeks after treatment
MRI
Baseline，12 weeks after treatment
Skin potential
Zeitfenster: 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.
Baseline，12 weeks after treatment
Polysomnography
Zeitfenster: Baseline，12 weeks after treatment
overnight polysomnography
Baseline，12 weeks after treatment
Change of the Brief Social Rhythm Scale (BSRS) score
Zeitfenster: Baseline，4，8，12 weeks after treatment
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）
Baseline，4，8，12 weeks after treatment
Neuropsychological tests
Zeitfenster: Baseline，12 weeks after treatment
Software testing (Prisoner's Dilemma game, Social searching task)
Baseline，12 weeks after treatment
Change of Beck Scale of Suicidal Ideation score
Zeitfenster: 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
Change of the Pittsburgh Sleep Quality Index (PSQI) score
Zeitfenster: Baseline，4，8，12 weeks after treatment
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
Change of the Young Mania Rating Scale (YMRS) score
Zeitfenster: Baseline，4，8，12 weeks after treatment
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
Change of Hamilton Anxiety Scale score
Zeitfenster: 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.
Baseline，4，8，12 weeks after treatment
Change of the Sociaty Adaptive Scale score
Zeitfenster: Baseline，4，8，12 weeks after treatment
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.
Baseline，4，8，12 weeks after treatment
blood
Zeitfenster: Baseline，12 weeks after treatment
Blood samples are collected to analyze the expression levels of peripheral circadian clock genes (PER1/PER2/PER3/BMAL1).
Baseline，12 weeks after treatment
saliva samples
Zeitfenster: Baseline，12 weeks after treatment
Saliva is employed for the analysis of cortisol and melatonin
Baseline，12 weeks after treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

First Affiliated Hospital of Zhejiang University

Mitarbeiter

Shanghai Mental Health Center
Second Xiangya Hospital of Central South University
Zhejiang Provincial Tongde Hospital
Brain Hospital Affiliated to Guangzhou Medical University
The Affiliated Hospital of Hangzhou Normal University
Hunan Mental Hospital
First Affiliated Hospital of Kunming Medical University
Brain Hospital Hunan Province

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juli 2029

Studienabschluss (Geschätzt)

1. Juli 2029

Studienanmeldedaten

Zuerst eingereicht

12. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juni 2026

Zuerst gepostet (Tatsächlich)

17. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IIT20250074C-R2

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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