Comparison of Orcinoside With Placebo in Treatment of MDD

Major Depressive Disorder (MDD) Clinical Trial

Official title:

Proof Of Concept Study of Orcinoside 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: NCT02191384
• Other study ID #: ASLST-MDD-?a-1401
• Secondary ID: 2012ZX09303-003
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: March 9, 2016

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 Orcinoside Capsule in different doses are effective in the treatment of Depression. And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in the Chinese Patients with Depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: March 9, 2016
• Est. primary completion date: March 9, 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 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 subject is an outpatient.
• The subject is a man or woman,aged=18 and =65 years.
• The total score of HAMD-17 is =18 and =24 in both screening visit and baseline visit.
• The subject is willing to take birth control measures during study period and one month after study.
• 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%.
• The subject has a current diagnosis or history of depression due to any other psychotic disorder or a general medical condition, bipolar disorder, or depression accompanied with psychotic symptoms.
• Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood,or other medical disease. Had a history of seizure disorder or other brain organic disorders.
• 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 Common Curculigo Rhizome or other drugs.
• Women who were pregnant, breast-feeding, or planning to become pregnant during study. Men who have request to fertility within half of year.
• Clinically significant electrocardiographic(ECG) abnormalities or abnormal laboratory values(eg. Hepatic function above 1.5 times of clinical toplimit, renal function above toplimit, blood glucose above toplimit, cardiac troponin abnormal, thyroid gland examine index significantly abnormal).
• 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 accepted electroconvulsive therapy within 3months.
• The subject has accepted system psychotherapy within 3 months.
• The compliance of the subject is poor.
• The subject has participated in a drug clinical trial within 30 days 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:
• Orcinoside
oral, twice per day

Locations

Country	Name	City	State
China	Hebei Province Mental Health Center	Baoding	Hebei
China	Peking University Sixth Hospital	Beijing	Beijing
China	Guangzhou Brain Hospital	Guangzhou	Guangdong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Wuhan Mental Health Center	Wuhan	Hubei
China	Wuxi Mental Health Center	Wuxi	Jiangsu
China	the first affiliated hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xi'an Mental Health Center	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Kun Ming KingBio Biotechnology Co. LTD

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang ZH, Huang J, Ma XC, Li GY, Ma YP, Li N, Wang JH. Phenolic glycosides from Curculigo orchioides Gaertn. Fitoterapia. 2013 Apr;86:64-9. doi: 10.1016/j.fitote.2013.01.008. Epub 2013 Jan 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	vital sign		6 weeks
Other	AE(adverse events)		6 weeks
Other	laboratory examination		6 weeks
Other	ECG		6 weeks
Other	C-SSRS		6 weeks
Primary	The change of total score from baseline in MADRS and HAMD scale		6 weeks
Secondary	response rate and remission rate		6 weeks
Secondary	decreasing rate from baseline in MADRS		6 weeks
Secondary	decreasing rate from baseline in HAMD scale		6 weeks
Secondary	change from baseline in HAMA		6 weeks
Secondary	CGI(CGI-S,CGI-I)		6 weeks
Secondary	sleep VAS scale.		6 weeks