Efficacy and Mechanism of IPSRT for Bipolar II Disorder

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.

Conditions

• Bipolar Disorder II

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)

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Guangzhou Mental Hospital

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Brain Hospital Hunan Province

  collaborator UNKNOWN

• Hunan Mental Hospital

  collaborator OTHER

• The Affiliated Hospital of Hangzhou Normal University

  collaborator OTHER

• Zhejiang Provincial Tongde Hospital

  collaborator OTHER

• Shanghai Mental Health Center

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2029-07-01

Completion

2029-07-01

Countries

• China

Study Locations