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Efficacy and Mechanism of IPSRT for Bipolar II Disorder

2026년 6월 12일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

216

단계

  • 2 단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 중국
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310000
        • The First Affiliated Hospital of Zhejiang 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: 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).

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: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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)
의약품: 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)
실험적: 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)
행동: 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)
다른 이름들:
  • Interpersonal and Social Rhythm Therapy (IPSRT)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Hamilton Depression Scale (17-items) Total Score Change
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score
기간: 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
기간: Baseline，12 weeks after treatment
MRI
Baseline，12 weeks after treatment
Skin potential
기간: 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
기간: Baseline，12 weeks after treatment
overnight polysomnography
Baseline，12 weeks after treatment
Change of the Brief Social Rhythm Scale (BSRS) score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline，12 weeks after treatment
Saliva is employed for the analysis of cortisol and melatonin
Baseline，12 weeks after treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

First Affiliated Hospital of Zhejiang University

협력자

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

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 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2029년 7월 1일

연구 완료 (추정된)

2029년 7월 1일

연구 등록 날짜

최초 제출

2026년 6월 12일

QC 기준을 충족하는 최초 제출

2026년 6월 12일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 12일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IIT20250074C-R2

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

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. .

양극성 장애 II에 대한 임상 시험

Quetiapine (drug)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Germany

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다