Not Yet RecruitingPhase 2

Efficacy and Mechanism of IPSRT for Bipolar II Disorder

China216 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hamilton Depression Scale (17-items) Total Score Change

Timeframe: Baseline，4，8，12 weeks after treatment

Trial details

NCT IDNCT07654348

SponsorFirst Affiliated Hospital of Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-07-01

Contact for this trial

Huang Manli, Professor

13957162975 Ext. 86 huangmanli@zju.edu.cn

View on ClinicalTrials.gov More Bipolar Disorder II trials