A Study of Dayingpian Treating Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05247593
• Other study ID #: SHDY2021CR2110C
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2022
• Source: Shanghai Mental Health Center
• Contact: Huafang LI, MD,PHD
• Phone: +86-2134773128
• Email: lhlh_5[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events	Number of participants with adverse events during the study.	12 weeks
Primary	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	Response rate	Response is defined as a reduction of at least 50% of the YMRS score compared with baseline.	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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