Major Depressive DisorderPhase 3NCT04210973
Comparison of Anyu Peibo With Placebo in Treatment of MDD in China
A Phase 3 study testing Anyu Peibo in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 15 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Anyu Peibo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 15 sitesChina
- Study dates
- 23 Jan 2020to May 2021
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria of DSM-5, single episode or recurrent episode. [296.21; 296.22; 296.23; 296.31; 296.32; 296.33]
- The total score of MADRS is ≥26 in both screening visit and baseline visit.
- The first item of MADRS is ≥3 in both screening visit and baseline visit.
- CGI-S is ≥4 in both screening visit and baseline visit.
- The subject understands and consents to takes part in this clinical trials. The subjects should sign informed consent form.
Who cannot join
- The subject has a current psychiatric diagnosis other than depression.
- The subject has a suicide attempt within recent 1 year, or has a currently significant risk of suicide, or has a score ≥3 on item 10 (suicidal ideation) of MADRS.
- The subject has a current depressive episode due to somatic general disease or a neurological disease, such as hypothyroidism.
- When the MADRS total score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
- Known hypersensitivity to Big Leaf Ju, or at least to two kinds of drugs.
- Any unstable cardiovascular, hepatic, renal, blood, endocrine, or other medical disease.
Show all 19Show fewer
- Any neurological disease (such as Parkinson's Disease, cerebrovascular accident and epilepsy) or cerebral injury (traumatic or disease related).
- Had a history or a high risk related disease or medication of seizure disorder, except infantile febrile convulsion.
- The subject could not take medication or has a disease affecting drug absorption, distribution, metabolism and excretion.
- Clinically significant electrocardiographic(ECG) abnormalities in screening visit. Such as QTc ≥450 ms in male or ≥470 ms in female.
- Clinically significant abnormal laboratory values (eg. ALT or AST value above 2 times of clinical top-limit; Cr value above normal top-limit; thyroid gland function index (≥ 2 items in 5 items) above 1.2 times or below 0.8 times of the normal range, or investigator diagnosed with hypothyroidism or hyperthyroidism).
- The subject who used at least two different antidepressants with recommended dose and adequate duration (maximum dosage by at least 4 weeks according to label) treatment still had no respond.
- The subject uses antidepressant drug normally before 2 weeks of screening, and stops using psychotropic drug before randomization less than 5 half-life period (monoamine oxidase inhibitor: at least 2 weeks; fluoxetine: at least 1 month).
- The subject received systematic light therapy, laser therapy and acupuncture or other Traditional Chinese Medicine, or systemic biofeedback therap within 2 weeks.
- The subject received modified ECT, trans-cranial magnetic stimulation (TMS), vagus nerve stimulation (VNS) or systematic psychotherapy within 3 months.
- Women who were pregnant, breast-feeding, or serum-HCG(+) on screening; or planning to become pregnant within 3 months after kick-off of clinical trial.
- Education level below junior high school.
- The subject has participated in a drug clinical trial within 1 month before screening.
- The investigator thinks the subject is unsuitable to enroll in this clinical trial.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
The Sixth People's Hospital of Hebei Province
Baoding, Hebei, 071000
Keqing LI, Master, 13703288007, like1002@sina.com
- Recruiting
Beijing Anding Hospital，Capital Medical University
Beijing, Beijing Municipality, 100088
Yazhou LU, MS, +86-10-58340310, wujinzhizunzhe@sina.com
- Recruiting
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, 100096
Yajuan NIU, MS, 18601360528, niuyajuan@126.com
- Recruiting
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
YI FU, Bachelor, 13683389877, fuyi757@sina.com
- Recruiting
Chongqing Mental Health Center
Chongqing, Chongqing Municipality, 400036
Xueqin YU, Bachelor, 13983656808, 243751089@qq.com
- Recruiting
Guangzhou Brain Hospital
Guangzhou, Guangdong, 510370
Xingbing HUANG, Master, 18922165289, hxbing2002@163.com
- Recruiting
Jiangxi Mental Hospital
Nanchang, Jiangxi, 330029
Kan LI, MS, 13517003676, 799171881@qq.com
- Recruiting
Ningbo Kangning Hospital
Ningbo, Zhejiang, 315201
Zezhong FANG, Master, 13957495039, nbfzz888@163.com
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Huafang Li, PH.D, 86-2134773107, lhlh_5@163.com
- Recruiting
Brain Hospital of Jilin Province
Siping, Jilin, 136000
Zhiping TAO, MS, 13843401817, taozhiping800@21cn.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Jing CHENG, PhD, 18086621321, 469061443@qq.com
- Recruiting
Wuxi Mental Health Center
Wuxi, Jiangsu, 214063
Guoqiang WANG, PhD, 13358118972, 13358118972@126.com
- Recruiting
XI'AN Mental Health Center
Xi’an, Shanxi, 710061
Bin WU, MS, 13572222831, wubing1616@163.com
- Recruiting
The Second Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453002
Ruiling ZHANG, PhD, 18537312153, zhangruilingxx@163.com
- Recruiting
Zhumadian mental Hospital
Zhumadian, Henan, 463000
Hongjun CAO, Bachelor, 13938358276, Doctorcao139383@126.com
About this study
Official title: Efficacy and Safety Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅲ Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial
The purpose of this study is to evaluate the efficacy and safety of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression.
- Conditions
- Major Depressive Disorder
- Being tested
- Anyu Peibo, 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.
Anyu PeiboDrug
Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
PlaceboDrug
Placebo Capsule, twice per day, oral after breakfast and supper
| Study group | Role | What they receive |
|---|---|---|
| Anyu Peibo | Experimental | Anyu Peibo Capsule, oral, 0.8g twice per day Receives: Drug: Anyu Peibo |
| Placebo | Placebo comparator | Placebo,oral, twice per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of total score from baseline in Montgomery Asberg Depression Rating Scale （MADRS）
the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
Measured: 8 weeks
Secondary outcomes (23)
Clinical Remission Rate according to total score of MADRS at the end of study
Remission=at the end of study, total score of MADRS ≤10, the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
Measured: 8 weeks
Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study
Remission=at the end of study, total score of HAMD17 ≤7, the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome
Measured: 8 weeks
The change of total score of MADRS by time
the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
Measured: 8 weeks
The change of total score from baseline in HAMD17
the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome
Measured: 8 weeks
The change of total score from baseline in Hamilton Anxiety Scale (HAMA)
the minimum and maximum values of HAMA are from 0 to 56, and higher scores mean a worse outcome
Measured: 8 weeks
The change of score from baseline in Clinical Global Impression-Severity of Illness (CGI-S)
the minimum and maximum values of CGI-S are from 1 to 7, and higher scores mean a worse outcome
Measured: 8 weeks
Clinical Global Impression-Severity of Illness (CGI-I) score
the minimum and maximum values of CGI-I are from 1 to 7, and higher scores mean a worse outcome
Measured: 8 weeks
The change of total score from baseline in Discriminative Scale Space Tracker (DSST)
the minimum and maximum values of DSST are from 0 to 90, and higher scores mean a better outcome
Measured: 8 weeks
The change of total score from baseline in Trail Making Test (TMT) A&B
the minimum and maximum values of TMT are from 0 to 300, and higher scores mean a worse outcome
Measured: 8 weeks
The change of total score from baseline in Sheehan Disability Scale (SDS)
the minimum and maximum values of SDS are from 0 to 10, and higher scores mean a worse outcome
Measured: 8 weeks
Proportion of subjects who withdrew from clinical trial due to poor efficacy
Investigator will assess subject's efficacy according to his/her clinical status with rating scales, including MADRS, HAMD17, HAMA and CGI, which already listed in Outcome
Measured: 8 weeks
Proportion of subjects who combined medication to treat insomnia
Measured: 8 weeks
Incidence rate of AE
AE=Adverse Events
Measured: 8 weeks
Breath Rate
per minutes
Measured: 8 weeks
Pulse Rate
per minutes
Measured: 8 weeks
Heartbeat Rate
per minutes
Measured: 8 weeks
Diastolic blood pressure
Sitting position, mmHg
Measured: 8 weeks
Systolic blood pressure
Sitting position, mmHg
Measured: 8 weeks
Electrocardiogram(ECG)
the number of subjects with abnormal ECG report by 12-lead electrocardiogram
Measured: 8 weeks
Assessment of Arizona Sexual Experience Scale (ASES)
the minimum and maximum values of ASES are from 1 to 6, and higher scores mean a worse outcome
Measured: 8 weeks
Number of Participants with AE result in early withdrawal from clinical trials
Measured: 8 weeks
Number of Participants with Serious Adverse Event (SAE) result in early withdrawal from clinical trials
Measured: 8 weeks
Number of Emerging AE during drug withdrawal period
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start23 Jan 2020
- Primary completionDec 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Su Zhou YiHua Biotechnology Co. LTD
- Responsible party
- Sponsor
- Investigators
- Huafang LI, MD. PhD., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210973
- Sponsor's protocol ID
- AYPB-MDD-Ⅲ-201901
- Other IDs
- 2018ZX09734-005
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang J, Yu Y, Jiang Y, Chen W, Li Y, Shen Y, Zheng Q, Li H. The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial. Trials. 2021 Sep 3;22(1):585. doi: 10.1186/s13063-021-05550-9.
PubMed 34479619
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅲ Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04210973
- Acronym / sponsor ID
- AYPB-MDD-Ⅲ-201901
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Su Zhou YiHua Biotechnology Co. LTD
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 26 Dec 2019 (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 purpose of this study is to evaluate the efficacy and safety of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression.
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 |
|---|---|---|
| Anyu Peibo | Experimental | Drug: Anyu PeiboAnyu Peibo Capsule, oral, 0.8g twice per day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo,oral, twice per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria of DSM-5, single episode or recurrent episode. [296.21; 296.22; 296.23; 296.31; 296.32; 296.33]
- The total score of MADRS is ≥26 in both screening visit and baseline visit.
- The first item of MADRS is ≥3 in both screening visit and baseline visit.
- CGI-S is ≥4 in both screening visit and baseline visit.
- The subject understands and consents to takes part in this clinical trials. The subjects should sign informed consent form.
Key exclusion criteria (19 listed)
- The subject has a current psychiatric diagnosis other than depression.
- The subject has a suicide attempt within recent 1 year, or has a currently significant risk of suicide, or has a score ≥3 on item 10 (suicidal ideation) of MADRS.
- The subject has a current depressive episode due to somatic general disease or a neurological disease, such as hypothyroidism.
- When the MADRS total score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
- Known hypersensitivity to Big Leaf Ju, or at least to two kinds of drugs.
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 |
|---|---|---|
| Anyu PeiboAnyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper | Drug | Anyu Peibo |
| PlaceboPlacebo Capsule, twice per day, oral after breakfast and supper | Drug | Placebo |
Primary outcome
The change of total score from baseline in Montgomery Asberg Depression Rating Scale （MADRS）
Time frame: 8 weeks
the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome
23 secondary outcomes
Clinical Remission Rate according to total score of MADRS at the end of study
Time frame: 8 weeks
Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study
Time frame: 8 weeks
The change of total score of MADRS by time
Time frame: 8 weeks
The change of total score from baseline in HAMD17
Time frame: 8 weeks
The change of total score from baseline in Hamilton Anxiety Scale (HAMA)
Time frame: 8 weeks
The change of score from baseline in Clinical Global Impression-Severity of Illness (CGI-S)
Time frame: 8 weeks
Clinical Global Impression-Severity of Illness (CGI-I) score
Time frame: 8 weeks
The change of total score from baseline in Discriminative Scale Space Tracker (DSST)
Time frame: 8 weeks
The change of total score from baseline in Trail Making Test (TMT) A&B
Time frame: 8 weeks
The change of total score from baseline in Sheehan Disability Scale (SDS)
Time frame: 8 weeks
Proportion of subjects who withdrew from clinical trial due to poor efficacy
Time frame: 8 weeks
Proportion of subjects who combined medication to treat insomnia
Time frame: 8 weeks
Incidence rate of AE
Time frame: 8 weeks
Breath Rate
Time frame: 8 weeks
Pulse Rate
Time frame: 8 weeks
Heartbeat Rate
Time frame: 8 weeks
Diastolic blood pressure
Time frame: 8 weeks
Systolic blood pressure
Time frame: 8 weeks
Electrocardiogram(ECG)
Time frame: 8 weeks
Assessment of Arizona Sexual Experience Scale (ASES)
Time frame: 8 weeks
Number of Participants with AE result in early withdrawal from clinical trials
Time frame: 8 weeks
Number of Participants with Serious Adverse Event (SAE) result in early withdrawal from clinical trials
Time frame: 8 weeks
Number of Emerging AE during drug withdrawal period
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 34479619Huang J, Yu Y, Jiang Y, Chen W, Li Y, Shen Y, Zheng Q, Li H. The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial. Trials. 2021 Sep 3;22(1):585. doi: 10.1186/s13063-021-05550-9.
- EMEA :Guideline on clinical investigation of medicinal products in the treatment of depression.Link provided by the sponsor.
- FDA.Major Depressive Disorder：Developing Drug for Treatment Guidance for Industry.Link provided by the sponsor.
- 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.
Huafang LI, MD. PhD. principal investigator
Shanghai Mental Health Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anyu Peibo in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 15 sites 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 19 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 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Huafang LI, MD. PhD. (86-21-34773107, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of total score from baseline in Montgomery Asberg Depression Rating Scale （MADRS） (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210973, which also lists 1 linked publication.
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 May 2020.