- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03183505
Comparison of Anyu Peibo With Placebo in Treatment of MDD,Ⅱb
January 19, 2019 updated by: Shanghai Mental Health Center
Safety and Efficacy Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅱb Stratified Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression.
And to provide some scientific evidence for protocol designing in following phase Ⅲ clinical trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100096
- Beijing Huilongguan Hospital
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Beijing, Beijing, China, 100088
- Beijing Anding Hospital,Capital Medical University
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Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Mental Health Center
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Jiangxi
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Nanchang, Jiangxi, China, 330029
- Jiangxi Mental Hospital
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Jilin
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Siping, Jilin, China, 136000
- Brain Hospital of Jilin Province
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Shanghai
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Shanghai, Shanghai, China, 200030
- Shanghai Mental Health Center
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Shanxi
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Xi'an, Shanxi, China, 710061
- Xi'an Mental Health Center
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria of DSM-5, single episode or recurrent episode.
- The total score of MADRS is ≥24 in both screening visit and baseline visit.
- The total score of HAMD-17 is ≥18 and the first item (depressed mood) is ≥2 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.
Exclusion Criteria:
- 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 3(suicide assessment) of the HAMD.
- The subject has a current psychiatric diagnosis other than depression.
- When the HAMD-17 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.
- Had a history of hyperthyroidism or hypothyroidism within recent 1 year and still taking medication.
- With psychotic symptoms.
- The subject has a history of mania episode, including manic, mixed, bipolar depression or rapid cycle attack.
- The subject has a current diagnosis of depression due to a somatic disease.
- The subject could not take medication or has a disease affecting drug absorption, such as active bowel disease, partial or total intestinal obstruction, or chronic diarrhea.
- Clinically significant electrocardiographic(ECG) abnormalities in screening visit. Such as QTc ≥450 ms in male or ≥470 ms in female; Sinus bradycardia and HR ≤ 50 bpm; Ⅲ atrioventricular block; atrial fibrillation, etc.
- Clinically significant abnormal laboratory values(eg. Routine blood value above or below 1.2 times of the normal range; urine WBC, RBC or protein ≥++; ALT or AST value above 1.5 times of clinical top-limit; BUN value above 1.2 times of top-limit; Cr value above normal top-limit; thyroid gland function index above or below 1.2 times of the normal range, Fasting plasma glucose value above 1.2 times of normal top-limit; blood fat value above 1.5 times of normal top-limit).
- 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 7 half-life period (monoamine oxidase inhibitor: at least 2 weeks; fluoxetine: at least 1 month)
- The subject received light therapy within 2 weeks.
- The subject received ECT, trans-cranial magnetic stimulation, or other physics therapy within 3 months.
- The subject received systematic psychotherapy (interpersonal relationship, psychoanalytic therapy, or cognitive behavioral therapy) within 3 months or plan to use systematic psychotherapy during the study period.
- The subject has a history of substance abuse (including alcohol, drug or other psychoactive substance) within 1 year before screening.
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anyu Peibo
Anyu Peibo Capsule, oral, 0.8g twice per day
|
Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
Other Names:
|
Placebo Comparator: Placebo
Placebo,oral, twice per day
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Placebo Capsule, twice per day, oral after breakfast and supper
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of total score from baseline in MADRS scale
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response Rate according to MADRS
Time Frame: 6 weeks
|
6 weeks
|
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Clinical Remission Rate according to MADRS
Time Frame: 6 weeks
|
6 weeks
|
|
Clinical Response Rate according to HAMD-17
Time Frame: 6 weeks
|
6 weeks
|
|
Clinical Remission Rate according to HAMD-17
Time Frame: 6 weeks
|
6 weeks
|
|
the Change of CGI (CGI-S, CGI-I) from baseline
Time Frame: 6 weeks
|
6 weeks
|
|
the Change of total score from baseline in HAMA
Time Frame: 6 weeks
|
Hamilton Anxiety Rating Scale
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Examination
Time Frame: 6 weeks
|
6 weeks
|
|
AE
Time Frame: 6 weeks
|
Adverse Events
|
6 weeks
|
Laboratory Examination
Time Frame: 6 weeks
|
Blood RT, Urinalysis, Hepatic function, Renal function, FBG, Lipid, CK, Thyroid Function Test and Serum-HCG(fertile women only)
|
6 weeks
|
the Change of ECG from baseline
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Huafang Li, Doctor, Shanghai Mental Health Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2017
Primary Completion (Actual)
October 5, 2018
Study Completion (Actual)
November 29, 2018
Study Registration Dates
First Submitted
June 5, 2017
First Submitted That Met QC Criteria
June 8, 2017
First Posted (Actual)
June 12, 2017
Study Record Updates
Last Update Posted (Actual)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 19, 2019
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYPB-MDD-Ⅱb-1701
- 2017ZX09304-020 (Other Grant/Funding Number: China National Major Project for IND)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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