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NCT Number: NCT07654348

Efficacy and Mechanism of IPSRT for Bipolar II Disorder

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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Key information

Conditions

Bipolar Disorder II Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location contact

Huang Manli, M.D

CONTACT

[email protected]

13957162975 Ext. 86

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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)

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)

Other names: Interpersonal and Social Rhythm Therapy (IPSRT)

Primary outcomes

  1. Hamilton Depression Scale (17-items) Total Score Change

    Time frame: 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.

Secondary outcomes

  1. Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score

    Time frame: 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.

  2. Neuroimaging

    Time frame: Baseline，12 weeks after treatment

    MRI

  3. Skin potential

    Time frame: 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.

  4. Polysomnography

    Time frame: Baseline，12 weeks after treatment

    overnight polysomnography

  5. Change of the Brief Social Rhythm Scale (BSRS) score

    Time frame: 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）

  6. Neuropsychological tests

    Time frame: Baseline，12 weeks after treatment

    Software testing (Prisoner's Dilemma game, Social searching task)

  7. Change of Beck Scale of Suicidal Ideation score

    Time frame: 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.

  8. Change of the Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: 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.

  9. Change of the Young Mania Rating Scale (YMRS) score

    Time frame: 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.

  10. Change of Hamilton Anxiety Scale score

    Time frame: 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.

  11. Change of the Sociaty Adaptive Scale score

    Time frame: 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.

  12. blood

    Time frame: Baseline，12 weeks after treatment

    Blood samples are collected to analyze the expression levels of peripheral circadian clock genes (PER1/PER2/PER3/BMAL1).

  13. saliva samples

    Time frame: Baseline，12 weeks after treatment

    Saliva is employed for the analysis of cortisol and melatonin

Study contacts

Contact information is provided by the study sponsor or research team.

Huang Manli, Professor

CONTACT

[email protected]

13957162975 Ext. 86

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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