A Study of Dayingpian Treating Bipolar Disorder

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05247593

Collaborator

(none)

308

Enrollment

Location

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Dayingpian Drug: conventional mood stabilizers

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

308 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Dayingpian exposure group 1 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 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. Drug: conventional mood stabilizers Patients in the group are treated with the standard level of conventional mood stabilizers provided by psychiatrists according to treatment guidelines for bipolar disorder.
Non-exposure group 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 Patients in the group are treated with the standard level of conventional mood stabilizers provided by psychiatrists according to treatment guidelines for bipolar disorder.
Dayingpian exposure group 2 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 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.

Arm

Intervention/Treatment

Dayingpian exposure group 1

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

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.

Drug: conventional mood stabilizers

Patients in the group are treated with the standard level of conventional mood stabilizers provided by psychiatrists according to treatment guidelines for bipolar disorder.

Non-exposure group

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

Patients in the group are treated with the standard level of conventional mood stabilizers provided by psychiatrists according to treatment guidelines for bipolar disorder.

Dayingpian exposure group 2

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

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.

Outcome Measures

Primary Outcome Measures

Change in the Young Mania Rating Scale (YMRS) scores compared with baseline [12 weeks]
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).

Secondary Outcome Measures

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

Other Outcome Measures

Incidence of adverse events [12 weeks]
Number of participants with adverse events during the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.