A Study of Dayingpian Treating Bipolar Disorder

Recruiting

• Conditions: Bipolar Disorder
• Interventions: Drug: conventional mood stabilizers; Drug: Dayingpian

• Registration Number: NCT05247593
• Lead Sponsor: Shanghai Mental Health Center

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.

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 Timeline

• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-21
• Study Start: 2022-08-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

1. Meets the International Classification of Diseases-10(ICD-10) criteria for Bipolar Disorder.
2. Outpatients or inpatients in Shanghai Mental Health Center.
3. Male or female subjects aged 14-65 years.
4. education of Junior high school or above.
5. The patient fully understands and signs the informed consent form.

Exclusion Criteria

1. Apparent violent aggression/suicide within the last two weeks.
2. Other patients that the investigator believes should not be included in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-exposure group	conventional mood stabilizers	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.
Dayingpian exposure group 1	Dayingpian	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.
Dayingpian exposure group 1	conventional mood stabilizers	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.
Dayingpian exposure group 2	Dayingpian	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
Response rate	12 weeks	Response is defined as a reduction of at least 50% of the YMRS score compared with baseline.
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).
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-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).

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China