Comparison of Orcinoside With Placebo in Treatment of MDD

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Drug: Orcinoside

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Sixth Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510370
      • Guangzhou Brain Hospital
  • Hebei
    • Baoding, Hebei, China, 071000
      • Hebei Province Mental Health Center
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Mental Health Center
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Nanjing Brain Hospital
    • Wuxi, Jiangsu, China, 214151
      • Wuxi Mental Health Center
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shanxi, China, 710061
      • Xi'an Mental Health Center
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-Ⅳ-TR axisⅠpsychiatric 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Orcinoside; oral, twice per day
Experimental: Orcinoside 25mg per day	Drug: Orcinoside; oral, twice per day
Experimental: Orcinoside 50mg per day	Drug: Orcinoside; oral, twice per day
Experimental: Orcinoside 100mg per day	Drug: Orcinoside; oral, twice per day
Experimental: Orcinoside 200mg per day	Drug: Orcinoside; oral, twice per day
Experimental: Orcinoside 400mg per day	Drug: Orcinoside; oral, twice per day
Experimental: Orcinoside 600mg per day	Drug: Orcinoside; oral, twice per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of total score from baseline in MADRS and HAMD scale	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
CGI(CGI-S,CGI-I)	6 weeks
decreasing rate from baseline in HAMD scale	6 weeks
change from baseline in HAMA	6 weeks
response rate and remission rate	6 weeks
decreasing rate from baseline in MADRS	6 weeks
sleep VAS scale.	6 weeks

Other Outcome Measures

Outcome Measure	Time Frame
ECG	6 weeks
AE(adverse events)	6 weeks
C-SSRS	6 weeks
vital sign	6 weeks
laboratory examination	6 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Kun Ming KingBio Biotechnology Co. LTD
• Investigators: Principal Investigator: Huafang LI, MD PhD, Shanghai Mental Health Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 9, 2016
• Study Completion (Actual): March 9, 2016

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 13, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ASLST-MDD-Ⅱa-1401; 2012ZX09303-003 (Other Identifier: China National Major Project)