Clinical trial NCT02380066: Comparison of Anyu Peibo With Placebo in Treatment of MDD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Su Zhou YiHua Biotechnology Co. LTD
First posted: 2015-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change of total score from baseline in MADRS scale
timeFrame: 6 weeks
Secondary outcomes:
measure: clinical response rate according to MADRS
timeFrame: 6 weeks
measure: clinical remission rate according to MADRS
timeFrame: 6 weeks
measure: CGI(CGI-S,CGI-I)
timeFrame: 6 weeks
measure: The change of total score from baseline in HAMD scale
timeFrame: 6 weeks
measure: decreasing rate from baseline in HAMD scale
timeFrame: 6 weeks
measure: clinical response rate according to HAMD
timeFrame: 6 weeks
measure: clinical remission rate according to HAMD
timeFrame: 6 weeks
measure: change from baseline in HAMA
timeFrame: 6 weeks
Other outcomes:
measure: vital sign
timeFrame: 6 weeks
measure: AE(adverse events)
timeFrame: 6 weeks
measure: laboratory examination
timeFrame: 6 weeks
measure: ECG
timeFrame: 6 weeks
measure: C-SSRS
timeFrame: 6 weeks
Locations:
city: Hefei
country: China
facility: Anhui province hospital of TCM
state: Anhui
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Huiai Hospital
state: Guangdong
city: Nanjing
country: China
facility: Jiangsu province hospital of TCM
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Mental Health Center
state: Jiangsu
Study officials:
affiliation: Shanghai Mental Health Center
name: Huafang LI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: