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Bipolar Disorder IIPhase 2NCT07654348

Efficacy and Mechanism of IPSRT for Bipolar II Disorder

A Phase 2 study testing Quetiapine (drug) and Psychopharmacological treatment in people with Bipolar Disorder II, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Bipolar Disorder II
What is being tested?
Quetiapine (drug) and Psychopharmacological treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteChina
Study dates
1 Jul 2026to 1 Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huang Manli, Professor contact

13957162975 Ext. 86

huangmanli@zju.edu.cn

China1 site

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310000

    Huang Manli, M.D, 13957162975 Ext. 86, huangmanli@zju.edu.cn

Other trials in China

About this study

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

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.

Being tested
Quetiapine (drug), Psychopharmacological treatment
Keywords
bipolar disorder II, interpersonal and social rhythm therapy
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • Psychopharmacological treatmentBehavioural

    Also called Interpersonal and Social Rhythm Therapy (IPSRT)

    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)

Study groups in NCT07654348
Study groupRoleWhat they receive
Group QActive comparatorPatients 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)
Receives: Drug: Quetiapine (drug)
Group IExperimentalPatients 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)
Receives: Behavioral: Psychopharmacological treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline，4，8，12 weeks after treatment

Secondary outcomes (13)

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

    The BRIAN comprises 18 items, which are divided in 3 areas: sleep and social rhythms, activities and eating pattern. The total score ranged from 18 to 72, a higher score suggested a more severe biological rhythm disturbance.

    Measured: Baseline，4，8，12 weeks after treatment

  2. Neuroimaging

    MRI

    Measured: Baseline，12 weeks after treatment

  3. Skin potential

    In a quiet environment, the subject's left hand was pre connected to a portable skin potential acquisition device to collect skin potential signals under different types of emotional stimulation task paradigms. After denoising, 10 time-domain eigenvalues and 8 time-frequency domain eigenvalues were obtained for each task.

    Measured: Baseline，12 weeks after treatment

  4. Polysomnography

    overnight polysomnography

    Measured: Baseline，12 weeks after treatment

  5. Change of the Brief Social Rhythm Scale (BSRS) score

    The BSRS assess the irregularity with which participants engage in basic daily activities during the workweek and on the weekend, using a scale ranging from 1 (very regularly) to 6 (very irregularly）

    Measured: Baseline，4，8，12 weeks after treatment

  6. Neuropsychological tests

    Software testing (Prisoner's Dilemma game, Social searching task)

    Measured: Baseline，12 weeks after treatment

  7. Change of Beck Scale of Suicidal Ideation score

    Beck Scale of Suicidal Ideation is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week. The BSI score ranges from 0 to 63, with higher scores indicating worse outcomes and lower scores indicating better outcomes.

    Measured: Baseline，4，8，12 weeks after treatment

  8. Change of the Pittsburgh Sleep Quality Index (PSQI) score

    The PSQI is a validated self-report questionnaire assessing sleep quality and disturbance over 1 month, quantifying 7 sleep-related domains, with higher scores indicating worse sleep quality.

    Measured: Baseline，4，8，12 weeks after treatment

  9. Change of the Young Mania Rating Scale (YMRS) score

    The Young Mania Rating Scale (YMRS) , is a 11 item diagnostic questionnaire used to measure the severity of mania symptom in patients with mood disorders.

    Measured: Baseline，4，8，12 weeks after treatment

  10. Change of Hamilton Anxiety Scale score

    Hamilton Anxiety Scale is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients. Each item on the scale is rated on a 5-point scale from 0 (not present) to 4 (severe), with the total score ranging from 0 to 68. The HAMA-17 is often used in clinical and research settings to assess the severity of anxiety symptoms and to evaluate the effectiveness of treatments for anxiety.

    Measured: Baseline，4，8，12 weeks after treatment

  11. Change of the Sociaty Adaptive Scale score

    SAS is a self-rating scale used to assess an individual's social functioning in areas such as work, study, interpersonal communication, and family life.

    Measured: Baseline，4，8，12 weeks after treatment

  12. blood

    Blood samples are collected to analyze the expression levels of peripheral circadian clock genes (PER1/PER2/PER3/BMAL1).

    Measured: Baseline，12 weeks after treatment

  13. saliva samples

    Saliva is employed for the analysis of cortisol and melatonin

    Measured: Baseline，12 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 Jul 2029 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07654348
Sponsor's protocol ID
IIT20250074C-R2
Status last verified
Jun 2026
First submitted
12 Jun 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quetiapine (drug) and Psychopharmacological treatment in people with Bipolar Disorder II, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huang Manli, Professor (13957162975 Ext. 86, huangmanli@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Scale (17-items) Total Score Change (time frame: Baseline，4，8，12 weeks after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07654348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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