A Study of Dayingpian Treating Bipolar Disorder

Shanghai Mental Health Center

Status: Enrolling

Conditions: Bipolar Disorder

Treatments: Drug: Dayingpian; Drug: conventional mood stabilizers

Study type: Observational

Funder types: Other

Identifiers

NCT05247593

SHDY2021CR2110C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 308 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

308 participants in 3 patient groups

Dayingpian exposure group 1

Description:

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.

Treatment:

Drug: conventional mood stabilizers

Drug: Dayingpian

Non-exposure group

Description:

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.

Treatment:

Drug: conventional mood stabilizers

Dayingpian exposure group 2

Description:

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.

Treatment:

Drug: Dayingpian