Comparison of Anyu Peibo With Placebo in Treatment of MDD in China

NCT04210973 | Unknown Phase 3 DMC

• 2 other identifiers: AYPB-MDD-Ⅲ-2019012018ZX09734-005
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (23)

• Clinical Remission Rate according to total score of MADRS at the end of study

  8 weeks

• Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study

  8 weeks

• The change of total score of MADRS by time

  8 weeks

• The change of total score from baseline in HAMD17

  8 weeks

• The change of total score from baseline in Hamilton Anxiety Scale (HAMA)

  8 weeks

Study Arms (2)

Anyu Peibo

EXPERIMENTAL

Anyu Peibo Capsule, oral, 0.8g twice per day

Drug: Anyu Peibo

Placebo

PLACEBO COMPARATOR

Placebo,oral, twice per day

Drug: Placebo

Interventions

Anyu Peibo DRUG

Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper

Anyu Peibo

Placebo DRUG

Placebo Capsule, twice per day, oral after breakfast and supper

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Su Zhou YiHua Biotechnology Co. LTD: collaborator

Study Sites (15)

Beijing Anding Hospital，Capital Medical University

Beijing, Beijing Municipality, 100088, China

RECRUITING

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, 100096, China

RECRUITING

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Chongqing Mental Health Center

Chongqing, Chongqing Municipality, 400036, China

RECRUITING

Guangzhou Brain Hospital

Guangzhou, Guangdong, 510370, China

RECRUITING

The Sixth People's Hospital of Hebei Province

Baoding, Hebei, 071000, China

RECRUITING

The Second Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453002, China

RECRUITING

Zhumadian mental Hospital

Zhumadian, Henan, 463000, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Wuxi Mental Health Center

Wuxi, Jiangsu, 214063, China

RECRUITING

Jiangxi Mental Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

Brain Hospital of Jilin Province

Siping, Jilin, 136000, China

RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

XI'AN Mental Health Center

Xi’an, Shanxi, 710061, China

RECRUITING

Ningbo Kangning Hospital

Ningbo, Zhejiang, 315201, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34479619 DERIVED

Related Links

• EMEA :Guideline on clinical investigation of medicinal products in the treatment of depression.
• FDA.Major Depressive Disorder：Developing Drug for Treatment Guidance for Industry.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Huafang LI, MD. PhD.

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huafang LI, MD. PhD.

CONTACT

86-21-34773107; lhlh_5@163.com

Yiming YU, Master

CONTACT

86-21-34773128; mindyfish2001@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 26, 2019
• Study Start: January 23, 2020
• Primary Completion: December 1, 2020
• Study Completion: May 1, 2021
• Last Updated: May 12, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)