Major Depressive DisorderPhase 2NCT04509882
Bear Bile Pill as add-on the Treatment of MDD
A Phase 2 study testing bear bile pill in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This is a single-center, double blind, randomized, placebo-controlled, parallel group study of bear bile pill, as add-on therapy in MDD patients conducted in Shang Hai Mental Health Center. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- bear bile pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to 31 Mar 2022
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition, Text Revision (DSM-V) criteria for Major Depressive Disorder (MDD); a single or recurrent episode without psychotic features ;Codes are as follows: F32.0、F32.1、F32.2、F33.0、F33.1 、F33.2.
- Outpatients or inpatients.
- Male or female subjects aged 18-65 years.
- Patients have got standard treatment of SSRI/SNRI monotherapy for more than 4 weeks in current episode of depression before trial entry.
- MADRS score greater than 20.
- Women of childbearing potential must be willing to use acceptable methods of contraception throughout the study period and the following one month.
- The patient the patient fully understand and signed the informed consent form
Who cannot join
- Patient has survived a suicide attempt or has acute suicidal tendencies (MADRS Item 10 > 4).
- Comorbidity according to DSM-V, axis I except major depressive disorder.
- Failed 3 or more adequate antidepressant courses in current episode of depression.
- MADRS reduction ratio ≥25% within one week from the screening to the baseline Visit.
- Depressive episode secondary to psychiatric illness or somatic disease.
- Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
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- History of alcohol or drug abuse over the last 6 months
- Allergic history to bear bile pills, or serious drug allergic history.
- Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within six months;
- Clinically significant changes in ECG or laboratory tests, including >1.5X upper limit of normal liver function、over the limit of normal renal function and blood sugar、abnormal cardiac troponins、obvious abnormity in the thyroid function
- Treatment with MECT or rTMS in nearly three months.
- Treatment with a systematic psychological treatment in nearly three months.
Trial locations and contacts
1 site in 1 country.
China1 site
Jing jing Huang
Shanghai
Jing jing Huang, Doctor, +86 021 34773308, jjhuang_att@163.com
About this study
Official title: Add-on Study of Bear Bile Pill for Patients With Major Depressive Disorder (MDD)
This is a single-center, double blind, randomized, placebo-controlled, parallel group study of bear bile pill, as add-on therapy in MDD patients conducted in Shang Hai Mental Health Center. The purpose of this study is to determine the efficacy and safety of bear bile pill in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy. Following a screening period, subjects who meet the entry criteria will be randomized to treated with either placebo or 450mg bear bile pill three times daily for 8 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- bear bile pill, placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bear bile pillDrug
Bear bile pill (15 pills) taken orally three times a day after meals with water.
placeboDrug
Placebo(15 pills) taken orally three times a day after meals with water.
| Study group | Role | What they receive |
|---|---|---|
| bear bile pill | Experimental | Patients randomized to the bear bile pill arm will receive treatment with 15 pills, three times daily of bear bile pill (1350mg per day) plus on-going antidepressant therapy (SSRI/SNRI). Receives: Drug: bear bile pill |
| placebo | Placebo comparator | Patients randomized to the placebo arm will receive 15 pills, three times daily of placebo plus on-going antidepressant therapy (SSRI/SNRI). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total Montgomery-Asberg Depression Rating Scale (MADRS) score between randomization and end of study.
The main objective is to explore whether bear bile pill add on SSRI or SNRI will improve the MDD symptoms after 8 weeks of treatment, and investigators assess the scale at baseline and week 1, 2, 4, 8.
Measured: assessed from baseline to week 8(end of study)
Secondary outcomes (7)
Effective treatment
effectivity：MADRS or HAMD reduction ratio ≥50% reductive ratio: [（Baseline score- Endpoint score）／Baseline score]×100%
Measured: assessed from baseline to week 8 (end of study)
Clinical remission rate
patients who are in remission at the end of the study will be summarized by treatment group, MADRS score ≤12 or HAMD-17≤7.
Measured: assessed from baseline to week 8 (end of study)
The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio
MADRS reduction ratio were used to evaluate the effectiveness of the treatment,and investigators assess the scale at baseline and week 1, 2, 4, 8.
Measured: assessed from baseline to week 8 (end of study)
The Hamilton Depression Rating Scale (HAM-D17) reduction ratio
the Hamilton Depression Rating Scale reduction ratio were used to evaluate the effectiveness of the treatment,and investigators assess the scale at baseline and week 1, 2, 4, 8.
Measured: assessed from baseline to week 8 (end of study)
change in the total score of the Hamilton Anxiety Scale(HAMA)
Measured: assessed from baseline to week 8 (end of study)
change in total score of the Clinical Global Impression-Severity (CGI-S) scale.
Measured: assessed from baseline to week 8 (end of study)
change in total score of the Clinical Global Impression-Improvement (CGI-I) scale.
Measured: assessed from baseline to week 8 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start30 Oct 2020 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingjing HUANG, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jingjing huang, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509882
- Sponsor's protocol ID
- NCTNCT04002259
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on Study of Bear Bile Pill for Patients With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT04509882
- Acronym / sponsor ID
- NCTNCT04002259
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 30 Oct 2020 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 12 Aug 2020 (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.
This is a single-center, double blind, randomized, placebo-controlled, parallel group study of bear bile pill, as add-on therapy in MDD patients conducted in Shang Hai Mental Health Center. The purpose of this study is to determine the efficacy and safety of bear bile pill in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy. Following a screening period, subjects who meet the entry criteria will be randomized to treated with either placebo or 450mg bear bile pill three times daily for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bear bile pill | Experimental | Drug: bear bile pillPatients randomized to the bear bile pill arm will receive treatment with 15 pills, three times daily of bear bile pill (1350mg per day) plus on-going antidepressant therapy (SSRI/SNRI). |
| placebo | Placebo comparator | Drug: placeboPatients randomized to the placebo arm will receive 15 pills, three times daily of placebo plus on-going antidepressant therapy (SSRI/SNRI). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meets the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition, Text Revision (DSM-V) criteria for Major Depressive Disorder (MDD); a single or recurrent episode without psychotic features ;Codes are as follows: F32.0、F32.1、F32.2、F33.0、F33.1 、F33.2.
- Outpatients or inpatients.
- Male or female subjects aged 18-65 years.
- Patients have got standard treatment of SSRI/SNRI monotherapy for more than 4 weeks in current episode of depression before trial entry.
- MADRS score greater than 20.
Key exclusion criteria (12 listed)
- Patient has survived a suicide attempt or has acute suicidal tendencies (MADRS Item 10 > 4).
- Comorbidity according to DSM-V, axis I except major depressive disorder.
- Failed 3 or more adequate antidepressant courses in current episode of depression.
- MADRS reduction ratio ≥25% within one week from the screening to the baseline Visit.
- Depressive episode secondary to psychiatric illness or somatic disease.
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 |
|---|---|---|
| bear bile pillBear bile pill (15 pills) taken orally three times a day after meals with water. | Drug | bear bile pill |
| placeboPlacebo(15 pills) taken orally three times a day after meals with water. | Drug | placebo |
Primary outcome
Change in the total Montgomery-Asberg Depression Rating Scale (MADRS) score between randomization and end of study.
Time frame: assessed from baseline to week 8(end of study)
The main objective is to explore whether bear bile pill add on SSRI or SNRI will improve the MDD symptoms after 8 weeks of treatment, and investigators assess the scale at baseline and week 1, 2, 4, 8.
7 secondary outcomes
Effective treatment
Time frame: assessed from baseline to week 8 (end of study)
Clinical remission rate
Time frame: assessed from baseline to week 8 (end of study)
The Montgomery-Asberg Depression Rating Scale (MADRS) reduction ratio
Time frame: assessed from baseline to week 8 (end of study)
The Hamilton Depression Rating Scale (HAM-D17) reduction ratio
Time frame: assessed from baseline to week 8 (end of study)
change in the total score of the Hamilton Anxiety Scale(HAMA)
Time frame: assessed from baseline to week 8 (end of study)
change in total score of the Clinical Global Impression-Severity (CGI-S) scale.
Time frame: assessed from baseline to week 8 (end of study)
change in total score of the Clinical Global Impression-Improvement (CGI-I) scale.
Time frame: assessed from baseline to week 8 (end of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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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.
Jingjing huang principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bear bile pill in people with Major Depressive 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 7 inclusion and 12 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 12 Aug 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jing jing Huang (+86 021 34773308, jjhuang_att@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 total Montgomery-Asberg Depression Rating Scale (MADRS) score between randomization and end of study. (time frame: assessed from baseline to week 8(end of study)). 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 12 Aug 2020.