Status:
COMPLETED
Comparison of Orcinoside With Placebo in Treatment of MDD
Lead Sponsor:
Shanghai Mental Health Center
Collaborating Sponsors:
Kun Ming KingBio Biotechnology Co. LTD
Conditions:
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2016
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT02191384
Start Date
July 1 2014
End Date
March 9 2016
Last Update
September 23 2021
Active Locations (10)
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1
Peking University Sixth Hospital
Beijing, Beijing Municipality, China, 100191
2
Guangzhou Brain Hospital
Guangzhou, Guangdong, China, 510370
3
Hebei Province Mental Health Center
Baoding, Hebei, China, 071000
4
Wuhan Mental Health Center
Wuhan, Hubei, China, 430022