Clinical trial NCT02395263: Comparison of Yuxintine With Placebo in Treatment of MDD
Official title: Proof Of Concept Study of Yuxintine in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Shanghai Innovative Research Center of Traditional Chinese Medicine
First posted: 2015-03-23
Enrollment: 160
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 Yuxintine Capsule in different doses are effective in the treatment of Depression.

And to explore the preliminary information of safety and efficacy of Yuxintine 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: 296.2 and 296.3.
* The Subject with Heart-Spleen Deficiency based on the CTM.
* The total score of MADRS is ≥22 in both screening visit and baseline visit.
* The total score of HAMD-17 is ≥18 and ≤30, AND item 1 ≥2 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 made a suicide attempt in recent 6 months or has a score ≥3 on item 3(suicide assessment) of the HAMD.
* The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
* When the MADRS score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
* Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood(e.g. bleeding tendency),or other medical disease.
* Had a history of seizure disorder,except infantile febrile convulsion.
* The subject has accepted psychosurgery or electroconvulsive therapy within 3 months.
* 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 index above toplimit, abnormal coagulation function and clinical significance of abnormality, i.e. Prothrombin time shorten or extend more than 3 seconds or a dynamic variation or APTT prolonged more than 10 seconds,AND fibrinogen L or been progressive decline, or \> 4.0 g/L).
* 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 Ginseng, 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.
* 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).
* The subject has participated in a drug clinical trial within 3 months 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 remission rate according to HAMD
timeFrame: 6 weeks
measure: change from baseline in HAMA
timeFrame: 6 weeks
measure: Traditional Chinese Medicine Syndrome Scale
timeFrame: 6 weeks
Other outcomes:
measure: vital sign
timeFrame: 6 weeks
measure: The Arizona Sexual Experience Scale (ASEX)
timeFrame: 6 weeks
measure: laboratory examination
timeFrame: 6 weeks
measure: AE(adverse events)
timeFrame: 6 weeks
measure: ECG
timeFrame: 6 weeks
measure: Early Termination
timeFrame: 6 weeks
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
state: Beijing
city: Chongqing
country: China
facility: the First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Shenzhen
country: China
facility: Shenzhen Mental Health Center
state: Guangdong
city: Nanning
country: China
facility: the People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Guiyang
country: China
facility: Affiliated Hospital of Guiyang Medical College
state: Guizhou
city: Shijiazhuang
country: China
facility: Hebei Mental Health Center
state: Hebei
city: Changsha
country: China
facility: Hunan Brain Hospital
state: Hunan
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
Study officials:
References: