The Efficacy and Mechanism of Different Intervention Strategy for Bipolar II Disorder Patients With Rhythm Disturbance
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 216
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).