Efficacy and Mechanism of IPSRT for Bipolar II Disorder

NCT07654348 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IIT20250074C-R2
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bipolar disorder II; interpersonal and social rhythm therapy

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale (17-items) Total Score Change

  The Hamilton Depression Scale (17-items), is a 17 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D17 score indicates more severe depression. A reduction of 50% or more in total score from Baseline indicates clinical response.

  Baseline，4，8，12 weeks after treatment

Secondary Outcomes (13)

• Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score

  Baseline，4，8，12 weeks after treatment

• Neuroimaging

  Baseline，12 weeks after treatment

• Skin potential

  Baseline，12 weeks after treatment

• Polysomnography

  Baseline，12 weeks after treatment

• Change of the Brief Social Rhythm Scale (BSRS) score

  Baseline，4，8，12 weeks after treatment

Study Arms (2)

Group Q

ACTIVE COMPARATOR

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)

Drug: Quetiapine (drug)

Group I

EXPERIMENTAL

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)

Behavioral: Psychopharmacological treatment

Interventions

Quetiapine (drug) 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)

Group Q

Psychopharmacological treatment BEHAVIORAL

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)

Also known as: Interpersonal and Social Rhythm Therapy (IPSRT)

Group I

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• : a primary diagnosis of bipolar II disorder in accordance with DSM-V criteria, in a current major depressive episode;
• : scoring ≥17 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)
• : scoring \<12 on the Young Mania Rating Scale (YMRS)
• : medication-free (≥4 weeks without psychotropics)
• : with rhythm disturbance, scoring \>26 on the Biological Rhythm Interview for Neuropsychiatry (BRIAN)
• : Understand written language and be able to conduct questionnaire survey
• : 18 to 60 years old, gender is not limited
• : the patient voluntarily participates, signs a written informed consent form, is willing to participate in the study and undergo evaluation
• : Han Chinese
• : Right-handedness

You may not qualify if:

• : diseases that may significantly increase research risks or interfere with the evaluation of results
• : patients with rapid-cycling bipolar disorder (with \>4 episodes within the past year);
• : any psychiatric or organic mental disorder, bipolar I disorder (BD I), current alcohol or drug dependence, borderline or antisocial personality disorder
• : patients currently receiving any psychological treatment or melatonin treatment intervention
• : patients with active suicidal ideation, HAMD-17 item 3 score ≥3
• : pregnant
• : patients with metal objects in the body (pacemaker, cochlear implant, implanted teeth, braces, metal foreign bodies, cardiac stent/intravascular coil, orthopedic steel plate, etc.) and other MRI examination contraindications (claustrophobia or inability to cooperate with the examination).

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• 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

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Huang Manli, Professor

CONTACT

13957162975 Ext. 86; huangmanli@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

CN (1)