Comparison of Yuxintine With Placebo in Treatment of MDD
NCT ID: NCT02395263
Last Updated: 2015-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
160 participants
INTERVENTIONAL
2015-03-31
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
And to explore the preliminary information of safety and efficacy of Yuxintine Capsule in the Chinese Patients with Depression.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Orcinoside With Placebo in Treatment of MDD
NCT02191384
Efficacy and Safety Study of Levomilnacipran Hydrochloride Extended-Release Capsules in Major Depressive Disorder
NCT07253207
A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder
NCT06796868
A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
NCT06958692
A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
NCT07300969
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Yuxintine 200mg per day
Yuxintine 200mg oral, once a day, 6 weeks
Yuxintine
Yuxintine 300mg per day
Yuxintine 300mg oral, once a day, 6 weeks
Yuxintine
Yuxintine 400mg per day
Yuxintine 400mg oral, once a day, 6 weeks
Yuxintine
Placebo
Placebo oral, once a day, 6 weeks
Yuxintine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Yuxintine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The Subject with Heart-Spleen Deficiency based on the CTM.
* The total score of MADRS is ≥22 in both screening visit and baseline visit.
* The total score of HAMD-17 is ≥18 and ≤30, AND item 1 ≥2 in both screening visit and baseline visit.
* The subject understands and consents to takes part in this clinical trials. The subjects should sign informed consent.
Exclusion Criteria
* The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
* When the MADRS score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
* Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood(e.g. bleeding tendency),or other medical disease.
* Had a history of seizure disorder,except infantile febrile convulsion.
* The subject has accepted psychosurgery or electroconvulsive therapy within 3 months.
* With psychotic symptoms.
* The subject has a history of mania episode, including manic, mixed or rapid cycle attack.
* The subject has a current diagnosis or history of depression due to any other psychotic disorder or a general medical condition.
* The subject with refractory depressive disorder,i.e.the patients who used at least two different mechanisms antidepressants with adequate dosage and duration treatment still had no respond.
* Clinically significant electrocardiographic(ECG) abnormalities or abnormal laboratory values(eg. Hepatic function above 1.5 times of clinical toplimit, renal function index above toplimit, abnormal coagulation function and clinical significance of abnormality, i.e. Prothrombin time shorten or extend more than 3 seconds or a dynamic variation or APTT prolonged more than 10 seconds,AND fibrinogen L or been progressive decline, or \> 4.0 g/L).
* 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 Ginseng, or at least to two kinds of drugs, or serious allergic physique.
* Women who were pregnant, breast-feeding, or planning to become pregnant during study. Men who have request to fertility during study period. The subject could not take safe and effective birth control measures.
* The subject could not take medication according to the doctor's advice.
* 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).
* The subject has participated in a drug clinical trial within 3 months before screening.
* The investigator think the subject is unsuitable to enrol in this clinical trial.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Innovative Research Center of Traditional Chinese Medicine
OTHER
Shanghai Mental Health Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, China
the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Shenzhen Mental Health Center
Shenzhen, Guangdong, China
the People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, China
Hebei Mental Health Center
Shijiazhuang, Hebei, China
Hunan Brain Hospital
Changsha, Hunan, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012ZX09303-003
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Yuxintine Capsule-MDD-Ⅱb
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.