Comparison of Orcinoside With Placebo in Treatment of MDD

NCT02191384 | Completed Phase 2 DMC

• 2 other identifiers: ASLST-MDD-Ⅱa-14012012ZX09303-003
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 10

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)

Outcome Measures

Primary Outcomes (1)

• The change of total score from baseline in MADRS and HAMD scale

  6 weeks

Secondary Outcomes (6)

• response rate and remission rate

  6 weeks

• decreasing rate from baseline in MADRS

  6 weeks

• decreasing rate from baseline in HAMD scale

  6 weeks

• change from baseline in HAMA

  6 weeks

• CGI(CGI-S,CGI-I)

  6 weeks

Other Outcomes (5)

• vital sign

  6 weeks

• AE(adverse events)

  6 weeks

• laboratory examination

  6 weeks

Study Arms (7)

Orcinoside 25mg per day

EXPERIMENTAL

Drug: Orcinoside

Orcinoside 50mg per day

EXPERIMENTAL

Drug: Orcinoside

Orcinoside 100mg per day

EXPERIMENTAL

Drug: Orcinoside

Orcinoside 200mg per day

EXPERIMENTAL

Drug: Orcinoside

Orcinoside 400mg per day

EXPERIMENTAL

Drug: Orcinoside

Orcinoside 600mg per day

EXPERIMENTAL

Drug: Orcinoside

placebo

PLACEBO COMPARATOR

Drug: Orcinoside

Interventions

Orcinoside DRUG

oral, twice per day

Orcinoside 100mg per day; Orcinoside 200mg per day; Orcinoside 25mg per day; Orcinoside 400mg per day; Orcinoside 50mg per day; Orcinoside 600mg per day; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Kun Ming KingBio Biotechnology Co. LTD: collaborator

Study Sites (10)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

Guangzhou Brain Hospital

Guangzhou, Guangdong, 510370, China

Location

Hebei Province Mental Health Center

Baoding, Hebei, 071000, China

Location

Wuhan Mental Health Center

Wuhan, Hubei, 430022, China

Location

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

Wuxi Mental Health Center

Wuxi, Jiangsu, 214151, China

Location

the first affiliated hospital of Xi'an Jiaotong University

Xi'an, Shan'xi, 710061, China

Location

Xi'an Mental Health Center

Xi'an, Shan'xi, 710061, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Related 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.

  PMID: 23353659 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Huafang LI, MD PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of MICT

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 16, 2014
• Study Start: July 1, 2014
• Primary Completion: March 9, 2016
• Study Completion: March 9, 2016
• Last Updated: September 23, 2021

Record last verified: 2015-03

Locations

CN (10)