Comparison of Orcinoside With Placebo in Treatment of MDD

• Sponsor: Shanghai Mental Health Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02191384
• Collaborator: Kun Ming KingBio Biotechnology Co. LTD (Other)
• Enrollment: 186
• Locations: 10
• Arms: 7
• Duration (Months): 20.3
• Patients Per Site: 18.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder (MDD)	Drug: Orcinoside	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Mar 9, 2016
• Actual Study Completion Date: Mar 9, 2016

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: placebo	Drug: Orcinoside; oral, twice per day

Outcome Measures

Primary Outcome Measures

1. The change of total score from baseline in MADRS and HAMD scale [6 weeks]

Secondary Outcome Measures

1. response rate and remission rate [6 weeks]

2. decreasing rate from baseline in MADRS [6 weeks]

3. decreasing rate from baseline in HAMD scale [6 weeks]

4. change from baseline in HAMA [6 weeks]

5. CGI(CGI-S,CGI-I) [6 weeks]

6. sleep VAS scale. [6 weeks]

Other Outcome Measures

1. vital sign [6 weeks]

2. AE(adverse events) [6 weeks]

3. laboratory examination [6 weeks]

4. ECG [6 weeks]

5. C-SSRS [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Sixth Hospital	Beijing	Beijing	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
5	Nanjing Brain Hospital	Nanjing	Jiangsu	China	210029
6	Wuxi Mental Health Center	Wuxi	Jiangsu	China	214151
7	Shanghai Mental Health Center	Shanghai	Shanghai	China	200030
8	the first affiliated hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China	710061
9	Xi'an Mental Health Center	Xi'an	Shanxi	China	710061
10	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China	650032

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Huafang LI, MD PhD, Shanghai Mental Health Center

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: LI, Huafang, Executive Director of MICT, Shanghai Mental Health Center
• ClinicalTrials.gov Identifier: NCT02191384
• Other Study ID Numbers: ASLST-MDD-Ⅱa-1401; 2012ZX09303-003
• First Posted: Jul 16, 2014
• Last Update Posted: Sep 23, 2021
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

No Results Posted as of Sep 23, 2021