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NOT YET RECRUITING
NCT07654348
PHASE2

Efficacy and Mechanism of IPSRT for Bipolar II Disorder

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2026-07-01

Completion Date

2029-07-01

Last Updated

2026-06-17

Healthy Volunteers

No

Interventions

DRUG

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)

BEHAVIORAL

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)

Locations (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China