Bipolar DisorderNCT05247593
A Study of Dayingpian Treating Bipolar Disorder
An observational study of Bipolar Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Dayingpian and conventional mood stabilizers
- Type of treatment
- Pill or oral medicine
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Outpatients or inpatients with bipolar disorder in Shanghai Mental Health Center are screened to participate in this study.
Who may be able to join
- 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.
Who cannot join
- Apparent violent aggression/suicide within the last two weeks.
- Other patients that the investigator believes should not be included in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Huafang LI, MD, PHD, +862134773128, lhlh_5@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Dayingpian, conventional mood stabilizers
- Keywords
- Cohort study, Bipolar disorder, Traditional Chinese Medicine, Efficacy, Dayingpian
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dayingpian; Drug: 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. Receives: 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. Receives: Drug: Dayingpian |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (5)
Response rate
Response is defined as a reduction of at least 50% of the YMRS score compared with baseline.
Measured: 12 weeks
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with baseline
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).
Measured: 12 weeks
Change in total score of the Clinical Global Impression-Severity (CGI-S) scale
To assess the severity of bipolar disorder with the scale at baseline and week 4, 8, 12(the end of study).
Measured: 12 weeks
Change in total score of the Clinical Global Impression-Improvement (CGI-I) scale
To assess the improvement of bipolar disorder with the scale at baseline and week 4, 8, 12(the end of study).
Measured: 12 weeks
Change of Traditional Chinese Medicine(TCM) syndromes scale
To assess the Traditional Chinese Medicine syndromes of patients with the scale at baseline and week 4, 8, 12(the end of study).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Aug 2022
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI, Huafang, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247593
- Sponsor's protocol ID
- SHDY2021CR2110C
- Status last verified
- Oct 2022
- First submitted
- 16 Feb 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Dayingpian in The Treatment of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05247593
- Acronym / sponsor ID
- SHDY2021CR2110C
- Conditions
- Bipolar Disorder
- Keywords
- Cohort study, Bipolar disorder, Traditional Chinese Medicine, Efficacy, Dayingpian
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dayingpian exposure group 1 | – | Drug: Dayingpian, Drug: conventional mood stabilizersThe 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. |
| Non-exposure group | – | Drug: conventional mood stabilizersThe 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. |
| Dayingpian exposure group 2 | – | Drug: DayingpianThe 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. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients or inpatients with bipolar disorder in Shanghai Mental Health Center are screened to participate in this study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Apparent violent aggression/suicide within the last two weeks.
- Other patients that the investigator believes should not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DayingpianThe 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 | Dayingpian exposure group 1, Dayingpian exposure group 2 |
| conventional mood stabilizersPatients in the group are treated with the standard level of conventional mood stabilizers provided by psychiatrists according to treatment guidelines for bipolar disorder. | Drug | Dayingpian exposure group 1, Non-exposure group |
Primary outcome
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).
5 secondary outcomes
Response rate
Time frame: 12 weeks
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with baseline
Time frame: 12 weeks
Change in total score of the Clinical Global Impression-Severity (CGI-S) scale
Time frame: 12 weeks
Change in total score of the Clinical Global Impression-Improvement (CGI-I) scale
Time frame: 12 weeks
Change of Traditional Chinese Medicine(TCM) syndromes scale
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huafang LI, MD,PHD (+86-2134773128, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Young Mania Rating Scale (YMRS) scores compared with baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.