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| Name | Class |
|---|---|
| Second Xiangya Hospital of Central South University | OTHER |
| Brain Hospital Affiliated to Guangzhou Medical University | UNKNOWN |
| First Affiliated Hospital of Kunming Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Q | Active Comparator | 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) |
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| Group I | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine (drug) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (17-items) Total Score Change | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score | 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 |
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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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang Manli, Professor | Contact | 13957162975 Ext. 86 | huangmanli@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Brain Hospital Hunan Province | UNKNOWN |
| Hunan Mental Hospital | OTHER |
| The Affiliated Hospital of Hangzhou Normal University | OTHER |
| Zhejiang Provincial Tongde Hospital | OTHER |
| Shanghai Mental Health Center | OTHER |
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| Psychopharmacological treatment | Behavioral | 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) |
|
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| Neuroimaging | MRI | Baseline，12 weeks after treatment |
| Skin potential | 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 | overnight polysomnography | Baseline，12 weeks after treatment |
| Change of the Brief Social Rhythm Scale (BSRS) score | 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 | Software testing (Prisoner's Dilemma game, Social searching task) | Baseline，12 weeks after treatment |
| Change of Beck Scale of Suicidal Ideation score | 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 | 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 | 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 | 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 | 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 | 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 | Saliva is employed for the analysis of cortisol and melatonin | Baseline，12 weeks after treatment |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |