Bipolar Disorder
Conditions
Keywords
Cohort study, Bipolar disorder, Traditional Chinese Medicine, Efficacy, Dayingpian
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.
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.
Interventions
DRUGDayingpian
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.
DRUGconventional 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.
Sponsors
Shanghai Mental Health Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Young Mania Rating Scale (YMRS) scores compared with baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 12 weeks | Response is defined as a reduction of at least 50% of the YMRS score compared with baseline. |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with baseline | 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). |
| Change in total score of the Clinical Global Impression-Improvement (CGI-I) scale | 12 weeks | To assess the improvement of bipolar disorder with the scale at baseline and week 4, 8, 12(the end of study). |
| Change of Traditional Chinese Medicine(TCM) syndromes scale | 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). |
| Change in total score of the Clinical Global Impression-Severity (CGI-S) scale | 12 weeks | To assess the severity of bipolar disorder with the scale at baseline and week 4, 8, 12(the end of study). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 12 weeks | Number of participants with adverse events during the study. |
Countries
China
Contacts
Primary ContactHuafang LI, MD,PHD
Outcome results
None listed