Health TrialsbyHealthPanel

Efficacy and Mechanism of IPSRT for Bipolar II Disorder

ConditionBipolar Disorder II
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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)

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: Group QActive comparator 1 intervention
Group B: Group IExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline，4，8，12 weeks after treatment

Secondary outcomes

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.

Time frame
Baseline，4，8，12 weeks after treatment
2

Neuroimaging

MRI

Time frame
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.

Time frame
Baseline，12 weeks after treatment
4

Polysomnography

overnight polysomnography

Time frame
Baseline，12 weeks after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Zhejiang University

Lead sponsor

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

Source ClinicalTrials.gov

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