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.

NCT Number	NCT07654348
Lead Sponsor	First Affiliated Hospital of Zhejiang University Collaborators: Second Xiangya Hospital of Central South University, Guangzhou Mental Hospital, First Affiliated Hospital of Kunming Medical University, Brain Hospital Hunan Province, Hunan Mental Hospital, The Affiliated Hospital of Hangzhou Normal University, Zhejiang Provincial Tongde Hospital, Shanghai Mental Health Center
Conditions	Bipolar Disorder II
Enrollment	216 participants
Start Date	2026-07-01
Primary Completion	2029-07-01 (estimated)
Study Completion	2029-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-17