Comparison of Anyu Peibo With Placebo in Treatment of MDD

Proof Of Concept Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical Trial

The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are effective in the treatment of Depression.

And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in the Chinese Patients with Depression.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Drug: Anyu Peibo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • Anhui province hospital of TCM
  • Beijing
    • Beijing, Beijing, China, 100053
      • Guang'anmen hospital
    • Beijing, Beijing, China, 100191
      • Peking University Sixth Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510370
      • Guangzhou Huiai Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital of TCM
    • Wuxi, Jiangsu, China, 214151
      • Wuxi mental health center

Participation Criteria

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-IV-TR, single episode or recurrent episode, not accompanied with psychotic symptoms. Coding of diagnosis included: 296.21 MDD single episode, mild 296.22 MDD single episode, moderate 296.31 MDD recurrent episode, mild 296.32 MDD recurrent episode, moderate
• The total score of HAMD-17 is ≥18 and ≤24 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.

Exclusion Criteria:

• The subject has a significant risk of suicide according to the investigator's opinion or has a score ≥3 on item 3(suicide assessment) of the HAMD or has made a suicide attempt.
• The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
• When the HAMD17 score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
• Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood,or other medical disease.
• Had a history of seizure disorder,except infantile febrile convulsion.
• The subject has accepted psychosurgery or electroconvulsive therapy within 3months.
• With psychotic symptoms.
• The subject has a history of mania episode, including manic, mixed or rapid cycle attack.
• The subject has a current diagnosis or history of depression due to any other psychotic disorder or a general medical condition.
• The subject with refractory depressive disorder,i.e.the patients who used at least two different mechanisms antidepressants with adequate dosage and duration treatment still had no respond.
• Clinically significant electrocardiographic(ECG) abnormalities or abnormal laboratory values(eg. Hepatic function above 1.5 times of clinical toplimit, renal function or thyroid gland function index above toplimit, routine blood, fasting blood glucose value above or below 1.1 times of the upper limit of normal or in 1.1 times with the clinical significance of abnormality).
• The subject has a diagnosis of alcohol or other substance abuse or dependence at least 1 years prior to the baseline visit.
• Known hypersensitivity to Big Leaf Ju, or at least to two kinds of drugs, or serious allergic physique.
• Women who were pregnant, breast-feeding, or planning to become pregnant during study. Men who have request to fertility during study period. The subject could not take safe and effective birth control measures.
• The subject could not take medication according to the doctor's advice. i.e. the compliance of the subject is poor.
• The subject uses antidepressant drug normally before 2 weeks of screening, and stops using psychotropic drug less than 7 half-life period (monoamine oxidase inhibitor more than 2 weeks, fluoxetine more than 1 month).
• The subject has participated in a drug clinical trial within 1 month before screening.
• The investigator think the subject is unsuitable to enrol in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo,oral, twice per day	Drug: Anyu Peibo; Placebo; Other Names: Placebo
Experimental: Anyu Peibo 0.4g per day; Anyu Peibo Capsule, oral, 0.2g twice per day	Drug: Anyu Peibo; Placebo; Other Names: Placebo
Experimental: Anyu Peibo 0.8g per day; Anyu Peibo Capsule, oral, 0.4g twice per day	Drug: Anyu Peibo; Placebo; Other Names: Placebo
Experimental: Anyu Peibo 1.2g per day; Anyu Peibo Capsule, oral, 0.6g twice per day	Drug: Anyu Peibo; Placebo; Other Names: Placebo
Experimental: Anyu Peibo 1.6g per day; Anyu Peibo Capsule, oral, 0.8g twice per day	Drug: Anyu Peibo; Placebo; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of total score from baseline in MADRS scale	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
clinical response rate according to MADRS	6 weeks
clinical remission rate according to MADRS	6 weeks
CGI(CGI-S,CGI-I)	6 weeks
The change of total score from baseline in HAMD scale	6 weeks
decreasing rate from baseline in HAMD scale	6 weeks
clinical remission rate according to HAMD	6 weeks
change from baseline in HAMA	6 weeks
clinical response rate according to HAMD	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG		6 weeks
vital sign	Blood pressure, heart rate, temperature and respiratory rate	6 weeks
AE(adverse events)		6 weeks
laboratory examination	Blood RT, Urinalysis,Hepatic function,Renal function,FBG,Lipid,CK,HBV,Thyroid Function Test and U-HCG	6 weeks
C-SSRS		6 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Su Zhou YiHua Biotechnology Co. LTD
• Investigators: Principal Investigator: Huafang LI, MD PhD, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: March 1, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2019
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: AYPB-MDD-Ⅱa-1401; 2012ZX09303-003 (Other Identifier: China National Major Project)