A Study of Dayingpian Treating Bipolar Disorder

October 18, 2022 updated by: LI, Huafang, Shanghai Mental Health Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huafang LI, MD,PHD
  • Phone Number: +86-2134773128
  • Email: lhlh_5@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
          • Huafang LI, MD, PHD
          • Phone Number: +862134773128
          • Email: lhlh_5@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatients or inpatients with bipolar disorder in Shanghai Mental Health Center are screened to participate in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Young Mania Rating Scale (YMRS) scores compared with baseline
Time Frame: 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).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 12 weeks
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
Time Frame: 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).
12 weeks
Change in total score of the Clinical Global Impression-Severity (CGI-S) scale
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 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).
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 12 weeks
Number of participants with adverse events during the study.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDY2021CR2110C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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