A Study of Dayingpian Treating Bipolar Disorder

NCT ID: NCT05247593

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Bipolar Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Dayingpian

Intervention Type DRUG

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

Intervention Type DRUG

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.

conventional mood stabilizers

Intervention Type DRUG

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.

Dayingpian

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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LI, Huafang

Executive Director of MICT

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huafang LI, MD,PHD

Role: CONTACT

+86-2134773128

Facility Contacts

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Huafang LI, MD, PHD

Role: primary

+862134773128

Other Identifiers

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SHDY2021CR2110C

Identifier Type: -

Identifier Source: org_study_id

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