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Not yet recruiting NCT07654348

Efficacy and Mechanism of IPSRT for Bipolar II Disorder

Phase II Interventional Bipolar Disorder II

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quetiapine (drug), Psychopharmacological treatment.
Who it may be relevant to
Registry conditions: Bipolar Disorder II. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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)

Primary outcome measures

  • Hamilton Depression Scale (17-items) Total Score Change [Time frame: Baseline，4，8，12 weeks after treatment]
Secondary outcome measures (12)
  • Change of The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) score [Time frame: Baseline，4，8，12 weeks after treatment]
  • Neuroimaging [Time frame: Baseline，12 weeks after treatment]
  • Skin potential [Time frame: Baseline，12 weeks after treatment]
  • Polysomnography [Time frame: Baseline，12 weeks after treatment]
  • Change of the Brief Social Rhythm Scale (BSRS) score [Time frame: Baseline，4，8，12 weeks after treatment]
  • Neuropsychological tests [Time frame: Baseline，12 weeks after treatment]
  • Change of Beck Scale of Suicidal Ideation score [Time frame: Baseline，4，8，12 weeks after treatment]
  • Change of the Pittsburgh Sleep Quality Index (PSQI) score [Time frame: Baseline，4，8，12 weeks after treatment]
  • Change of the Young Mania Rating Scale (YMRS) score [Time frame: Baseline，4，8，12 weeks after treatment]
  • Change of Hamilton Anxiety Scale score [Time frame: Baseline，4，8，12 weeks after treatment]
  • Change of the Sociaty Adaptive Scale score [Time frame: Baseline，4，8，12 weeks after treatment]
  • blood [Time frame: Baseline，12 weeks after treatment]

Eligibility criteria

Inclusion criteria

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

2: scoring ≥17 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)

3: scoring <12 on the Young Mania Rating Scale (YMRS)

4: medication-free (≥4 weeks without psychotropics)

5: with rhythm disturbance, scoring >26 on the Biological Rhythm Interview for Neuropsychiatry (BRIAN)

6: Understand written language and be able to conduct questionnaire survey

7: 18 to 60 years old, gender is not limited

8: the patient voluntarily participates, signs a written informed consent form, is willing to participate in the study and undergo evaluation

9: Han Chinese

10: Right-handedness

Exclusion criteria

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

2: patients with rapid-cycling bipolar disorder (with >4 episodes within the past year);

3: any psychiatric or organic mental disorder, bipolar I disorder (BD I), current alcohol or drug dependence, borderline or antisocial personality disorder

4: patients currently receiving any psychological treatment or melatonin treatment intervention

5: patients with active suicidal ideation, HAMD-17 item 3 score ≥3

6: pregnant

7: 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Zhejiang University — Hangzhou

Identifiers

NCT: NCT07654348 · IIT20250074C-R2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗