Comparison of Yuxintine With Placebo in Treatment of MDD

Major Depressive Disorder (MDD) Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02395263
• Other study ID #: Yuxintine Capsule-MDD-?b
• Secondary ID: 2012ZX09303-003
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 17, 2015
• Last updated: March 20, 2015
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: March 2015
• Source: Shanghai Mental Health Center
• Contact: Huafang LI, MD PhD
• Phone: 86-21-34773128
• Email: lhlh_5[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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-?-TR axis?psychiatric 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder (MDD)

Intervention

Drug:
• Yuxintine

Locations

Country	Name	City	State
China	Beijing HuiLongGuan Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	Hunan Brain Hospital	Changsha	Hunan
China	the First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Affiliated Hospital of Guiyang Medical College	Guiyang	Guizhou
China	the People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Shenzhen Mental Health Center	Shenzhen	Guangdong
China	Hebei Mental Health Center	Shijiazhuang	Hebei
China	Tianjin Anding Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Shanghai Innovative Research Center of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	vital sign	Blood pressure, heart rate, temperature and respiratory rate	6 weeks	Yes
Other	The Arizona Sexual Experience Scale (ASEX)		6 weeks	Yes
Other	laboratory examination	Blood RT, Urinalysis,Hepatic function,Renal function,FBG,Lipid,Thyroid Function, Blood Coagulation Test and U-HCG	6 weeks	Yes
Other	AE(adverse events)		6 weeks	Yes
Other	ECG		6 weeks	Yes
Other	Early Termination		6 weeks	No
Primary	The change of total score from baseline in MADRS scale		6 weeks	No
Secondary	clinical response rate according to MADRS		6 weeks	No
Secondary	clinical remission rate according to MADRS		6 weeks	No
Secondary	CGI(CGI-S,CGI-I)		6 weeks	No
Secondary	The change of total score from baseline in HAMD scale		6 weeks	No
Secondary	decreasing rate from baseline in HAMD scale		6 weeks	No
Secondary	clinical remission rate according to HAMD		6 weeks	No
Secondary	change from baseline in HAMA		6 weeks	No
Secondary	Traditional Chinese Medicine Syndrome Scale		6 weeks	No