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Набор скоро начнётся NCT07654348

Efficacy and Mechanism of IPSRT for Bipolar II Disorder

Фаза II С лечением Bipolar Disorder II

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Quetiapine (drug), Psychopharmacological treatment.
Кому может быть актуально
Состояния в реестре: Bipolar Disorder II. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Efficacy and Mechanism of Different Intervention Strategy for Bipolar II Disorder Patients With Rhythm Disturbance

Обзор

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.

Вмешательства

  • Препарат 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)
  • Поведенческое 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)

Первичные конечные точки

  • Hamilton Depression Scale (17-items) Total Score Change [Срок оценки: Baseline，4，8，12 weeks after treatment]
Вторичные конечные точки (12)
  • Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score [Срок оценки: Baseline，4，8，12 weeks after treatment]
  • Neuroimaging [Срок оценки: Baseline，12 weeks after treatment]
  • Skin potential [Срок оценки: Baseline，12 weeks after treatment]
  • Polysomnography [Срок оценки: Baseline，12 weeks after treatment]
  • Change of the Brief Social Rhythm Scale (BSRS) score [Срок оценки: Baseline，4，8，12 weeks after treatment]
  • Neuropsychological tests [Срок оценки: Baseline，12 weeks after treatment]
  • Change of Beck Scale of Suicidal Ideation score [Срок оценки: Baseline，4，8，12 weeks after treatment]
  • Change of the Pittsburgh Sleep Quality Index (PSQI) score [Срок оценки: Baseline，4，8，12 weeks after treatment]
  • Change of the Young Mania Rating Scale (YMRS) score [Срок оценки: Baseline，4，8，12 weeks after treatment]
  • Change of Hamilton Anxiety Scale score [Срок оценки: Baseline，4，8，12 weeks after treatment]
  • Change of the Sociaty Adaptive Scale score [Срок оценки: Baseline，4，8，12 weeks after treatment]
  • blood [Срок оценки: Baseline，12 weeks after treatment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital of Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07654348 · IIT20250074C-R2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗