Comparison of Anyu Peibo With Placebo in Treatment of MDD

Major Depressive Disorder (MDD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380066
• Other study ID #: AYPB-MDD-?a-1401
• Secondary ID: 2012ZX09303-003
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: January 2017

Study information

• Verified date: March 2015
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• 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: 296.21 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-?-TR axis?psychiatric 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Anyu Peibo
Placebo

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	Guangzhou Huiai Hospital	Guangzhou	Guangdong
China	Anhui province hospital of TCM	Hefei	Anhui
China	Jiangsu province hospital of TCM	Nanjing	Jiangsu
China	Wuxi Mental Health Center	Wuxi	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Su Zhou YiHua Biotechnology Co. LTD

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
Other	AE(adverse events)		6 weeks
Other	laboratory examination	Blood RT, Urinalysis,Hepatic function,Renal function,FBG,Lipid,CK,HBV,Thyroid Function Test and U-HCG	6 weeks
Other	ECG		6 weeks
Other	C-SSRS		6 weeks
Primary	The change of total score from baseline in MADRS scale		6 weeks
Secondary	clinical response rate according to MADRS		6 weeks
Secondary	clinical remission rate according to MADRS		6 weeks
Secondary	CGI(CGI-S,CGI-I)		6 weeks
Secondary	The change of total score from baseline in HAMD scale		6 weeks
Secondary	decreasing rate from baseline in HAMD scale		6 weeks
Secondary	clinical response rate according to HAMD		6 weeks
Secondary	clinical remission rate according to HAMD		6 weeks
Secondary	change from baseline in HAMA		6 weeks