Can social rhythm therapy replace meds for bipolar II?
NCT ID NCT07654348
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial compares the drug quetiapine with interpersonal and social rhythm therapy (IPSRT) in 216 people with bipolar II disorder who have disrupted daily rhythms. Participants will be randomly assigned to one of the two treatments for 12 weeks. Researchers will measure changes in depression severity, biological rhythms, and explore how IPSRT might work by looking at stress hormones and brain activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- quetiapine
- What this could lead to
- If successful, this could show that social rhythm therapy is a safe, effective alternative or addition to medication for managing bipolar II depression.
- What could go wrong
- This is an early phase 2 trial with only 216 participants, so results may not apply broadly. Quetiapine has known side effects, and the therapy requires weekly sessions for 12 weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000, China
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