A Study of Dayingpian Treating Bipolar Disorder

Study Overview
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Brief Summary
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The main purpose of this cohort study is to evaluate the efficiency and safety of Dayingpian to provide evidence-based medical evidence for the subsequent drug development.

Detailed Description
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Dayingpian is a kind of formula in traditional Chinese medicine with the effect of promoting blood circulation and reducing blood stasis. It has been prescribed as an add-on in the treatment of mental disorders such as bipolar disorder. However, there is not yet much high-quality evidence of the clinical effectiveness of Dayingpian treatment. In this study, we conduct a prospective, real-world longitudinal cohort study at Shanghai Mental Health Center in China to investigate the efficacy and safety of Dayingpian for bipolar disorder patients. The observation period is 12 weeks and all participants are evaluated every 4 weeks.

Official Title
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The Efficacy and Safety of Dayingpian in The Treatment of Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Dayingpian
* Drug: conventional mood stabilizers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets the International Classification of Diseases-10(ICD-10) criteria for Bipolar Disorder. Outpatients or inpatients in Shanghai Mental Health Center. Male or female subjects aged 14-65 years. education of Junior high school or above. The patient fully understands and signs the informed consent form. Exclusion Criteria: Apparent violent aggression/suicide within the last two weeks. Other patients that the investigator believes should not be included in the study.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dayingpian exposure group 1<br>The exposure of interest is Dayingpian. Patients in this group take Dayingpian combined with conventional mood stabilizers. The psychiatrist does not assign specific interventions to the study participants. The course of observation is 12 weeks. | Drug: Dayingpian<br>* The actual dosage of Dayingpian is adjusted according to the patient's condition. The recommended dosage of Dayingpian is 5-10 tablets each time, 2-3 times a day.<br>Drug: conventional mood stabilizers<br>* Patients in the group are treated with the standard level of conventional mood stabilizers provided by psychiatrists according to treatment guidelines for bipolar disorder.<br>|
| Non-exposure group<br>The non-exposure group is the patients who do not take Dayingpian. Patients in this group take conventional mood stabilizers. The psychiatrist does not assign specific interventions to the study participants. The course of observation is 12 weeks. | Drug: conventional mood stabilizers<br>* Patients in the group are treated with the standard level of conventional mood stabilizers provided by psychiatrists according to treatment guidelines for bipolar disorder.<br>|
| Dayingpian exposure group 2<br>The exposure of interest is Dayingpian. Patients in this group take Dayingpian as monotherapy for bipolar disorder. The psychiatrist does not assign specific interventions to the study participants. The course of observation is 12 weeks. | Drug: Dayingpian<br>* The actual dosage of Dayingpian is adjusted according to the patient's condition. The recommended dosage of Dayingpian is 5-10 tablets each time, 2-3 times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Young Mania Rating Scale (YMRS) scores compared with baseline | To assess the mania symptoms of bipolar disorder patients after 12 weeks of treatment. Patients are assessed with the scale at baseline and week 4, 8, 12(the end of study). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response is defined as a reduction of at least 50% of the YMRS score compared with baseline. | 12 weeks | 
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with baseline | To assess the depression symptoms of bipolar disorder patients after 12 weeks of treatment. Patients are assessed with the scale at baseline and week 4, 8, 12(the end of study). | 12 weeks | 
| Change in total score of the Clinical Global Impression-Severity (CGI-S) scale | To assess the severity of bipolar disorder with the scale at baseline and week 4, 8, 12(the end of study). | 12 weeks | 
| Change in total score of the Clinical Global Impression-Improvement (CGI-I) scale | To assess the improvement of bipolar disorder with the scale at baseline and week 4, 8, 12(the end of study). | 12 weeks | 
| Change of Traditional Chinese Medicine(TCM) syndromes scale | To assess the Traditional Chinese Medicine syndromes of patients with the scale at baseline and week 4, 8, 12(the end of study). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cohort study, Bipolar disorder, Traditional Chinese Medicine, Efficacy, Dayingpian