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Efficacy and Mechanism of IPSRT for Bipolar II Disorder

2026年6月12日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

216

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310000
        • The First Affiliated Hospital of Zhejiang University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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)
薬：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)
実験的：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)
行動：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)
他の名前：
  • Interpersonal and Social Rhythm Therapy (IPSRT)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Hamilton Depression Scale (17-items) Total Score Change
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score
時間枠：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
時間枠：Baseline，12 weeks after treatment
MRI
Baseline，12 weeks after treatment
Skin potential
時間枠：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
時間枠：Baseline，12 weeks after treatment
overnight polysomnography
Baseline，12 weeks after treatment
Change of the Brief Social Rhythm Scale (BSRS) score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline，12 weeks after treatment
Saliva is employed for the analysis of cortisol and melatonin
Baseline，12 weeks after treatment

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

First Affiliated Hospital of Zhejiang University

協力者

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2029年7月1日

研究の完了 (推定)

2029年7月1日

試験登録日

最初に提出

2026年6月12日

QC基準を満たした最初の提出物

2026年6月12日

最初の投稿 (実際)

2026年6月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月17日

QC基準を満たした最後の更新が送信されました

2026年6月12日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • IIT20250074C-R2

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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