Comparison of Orcinoside With Placebo in Treatment of MDD

NCT ID: NCT02191384

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-03-09

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 of Orcinoside Capsule in the Chinese Patients with Depression.

Conditions

Major Depressive Disorder (MDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Orcinoside 25mg per day

Group Type: EXPERIMENTAL

Orcinoside

Intervention Type: DRUG

oral, twice per day

Orcinoside 50mg per day

Group Type: EXPERIMENTAL

Orcinoside

Intervention Type: DRUG

oral, twice per day

Orcinoside 100mg per day

Group Type: EXPERIMENTAL

Orcinoside

Intervention Type: DRUG

oral, twice per day

Orcinoside 200mg per day

Group Type: EXPERIMENTAL

Orcinoside

Intervention Type: DRUG

oral, twice per day

Orcinoside 400mg per day

Group Type: EXPERIMENTAL

Orcinoside

Intervention Type: DRUG

oral, twice per day

Orcinoside 600mg per day

Group Type: EXPERIMENTAL

Orcinoside

Intervention Type: DRUG

oral, twice per day

placebo

Group Type: PLACEBO_COMPARATOR

Orcinoside

Intervention Type: DRUG

oral, twice per day

Interventions

Orcinoside

oral, twice per day

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kun Ming KingBio Biotechnology Co. LTD

UNKNOWN

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

LI, Huafang

Executive Director of MICT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huafang LI, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Guangzhou Brain Hospital

Guangzhou, Guangdong, China

Hebei Province Mental Health Center

Baoding, Hebei, China

Wuhan Mental Health Center

Wuhan, Hubei, China

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Wuxi Mental Health Center

Wuxi, Jiangsu, China

the first affiliated hospital of Xi'an Jiaotong University

Xi'an, Shan'xi, China

Xi'an Mental Health Center

Xi'an, Shan'xi, China

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 23353659 (View on PubMed)

Other Identifiers

2012ZX09303-003

Identifier Type: OTHER

Identifier Source: secondary_id

ASLST-MDD-Ⅱa-1401

Identifier Type: -

Identifier Source: org_study_id