Efficacy and Mechanism of IPSRT for Bipolar II Disorder

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

1: a primary diagnosis of bipolar II disorder in accordance with DSM-V criteria, in a current major depressive episode;

Disqualifiers

1: diseases that may significantly increase research risks or interfere with the evaluation of results

Trial design

Treatments tested in this trial

  • Quetiapine (drug)
  • Psychopharmacological treatment

Treatment groups

216 Participants
are divided into 2 treatment groups

Sponsors and collaborators

First Affiliated Hospital of Zhejiang University

Lead sponsor

Second Xiangya Hospital of Central South University

Collaborator

Brain Hospital Affiliated to Guangzhou Medical University

Collaborator

First Affiliated Hospital of Kunming Medical University

Collaborator

Brain Hospital Hunan Province

Collaborator

Hunan Mental Hospital

Collaborator

The Affiliated Hospital of Hangzhou Normal University

Collaborator

Zhejiang Provincial Tongde Hospital

Collaborator

Shanghai Mental Health Center

Collaborator