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Comparison of Anyu Peibo With Placebo in Treatment of MDD,Ⅱb

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ClinicalTrials.gov Identifier: NCT03183505
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Su Zhou YiHua Biotechnology Co. LTD
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Anyu Peibo Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : November 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anyu Peibo
Anyu Peibo Capsule, oral, 0.8g twice per day
Drug: Anyu Peibo
Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
Other Name: Anyu Peibo Capsule

Placebo Comparator: Placebo
Placebo,oral, twice per day
Drug: Placebo
Placebo Capsule, twice per day, oral after breakfast and supper




Primary Outcome Measures :
  1. The change of total score from baseline in MADRS scale [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Clinical Response Rate according to MADRS [ Time Frame: 6 weeks ]
  2. Clinical Remission Rate according to MADRS [ Time Frame: 6 weeks ]
  3. Clinical Response Rate according to HAMD-17 [ Time Frame: 6 weeks ]
  4. Clinical Remission Rate according to HAMD-17 [ Time Frame: 6 weeks ]
  5. the Change of CGI (CGI-S, CGI-I) from baseline [ Time Frame: 6 weeks ]
  6. the Change of total score from baseline in HAMA [ Time Frame: 6 weeks ]
    Hamilton Anxiety Rating Scale


Other Outcome Measures:
  1. Physical Examination [ Time Frame: 6 weeks ]
  2. AE [ Time Frame: 6 weeks ]
    Adverse Events

  3. 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)

  4. the Change of ECG from baseline [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183505


Locations
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China, Beijing
Beijing Anding Hospital,Capital Medical University
Beijing, Beijing, China, 100088
Beijing HuiLongGuan Hospital
Beijing, Beijing, China, 100096
China, Hubei
Wuhan Mental Health Center
Wuhan, Hubei, China, 430022
China, Jiangxi
Jiangxi Mental Hospital
Nanchang, Jiangxi, China, 330029
China, Jilin
Brain Hospital of Jilin Province
Siping, Jilin, China, 136000
China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
China, Shanxi
XI'AN Mental Health Center
Xi'an, Shanxi, China, 710061
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Shanghai Mental Health Center
Su Zhou YiHua Biotechnology Co. LTD
Investigators
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Principal Investigator: Huafang LI, Doctor Shanghai Mental Health Center

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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03183505     History of Changes
Other Study ID Numbers: AYPB-MDD-Ⅱb-1701
2017ZX09304-020 ( Other Grant/Funding Number: China National Major Project for IND )
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms