NCT05247593

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

1.8 years

First QC Date

February 16, 2022

Last Update Submit

October 18, 2022

Conditions

Bipolar Disorder

Keywords

Cohort studyBipolar disorderTraditional Chinese MedicineEfficacyDayingpian

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Response rate

    12 weeks

  • Change in the Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with baseline

    12 weeks

  • Change in total score of the Clinical Global Impression-Severity (CGI-S) scale

    12 weeks

  • Change in total score of the Clinical Global Impression-Improvement (CGI-I) scale

    12 weeks

  • Change of Traditional Chinese Medicine(TCM) syndromes scale

    12 weeks

Other Outcomes (1)

  • Incidence of adverse events

    12 weeks

Study Arms (3)

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: DayingpianDrug: conventional mood stabilizers

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

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

Interventions

DayingpianDRUG

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.

Dayingpian exposure group 1Dayingpian exposure group 2
conventional mood stabilizersDRUG

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 1Non-exposure group

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Central Study Contacts

Huafang LI, MD,PHD

CONTACT

+86-2134773128lhlh_5@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director of MICT

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 21, 2022

Study Start

August 1, 2022

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)