Comparison of Yuxintine With Placebo in Treatment of MDD

Shanghai Mental Health Center

Status and phase: Unknown; Phase 2

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: Yuxintine

Study type: Interventional

Funder types: Other

Identifiers

NCT02395263

Yuxintine Capsule-MDD-Ⅱb

2012ZX09303-003 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether Yuxintine Capsule in different doses are effective in the treatment of Depression.

And to explore the preliminary information of safety and efficacy of Yuxintine Capsule in the Chinese Patients with Depression.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria of DSM-IV-TR, single episode or recurrent episode, not accompanied with psychotic symptoms. Coding of diagnosis included: 296.2 and 296.3.
• 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 made a suicide attempt in recent 6 months or has a score ≥3 on item 3(suicide assessment) of the HAMD.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

Yuxintine 200mg per day

Experimental group

Description:

Yuxintine 200mg oral, once a day, 6 weeks

Treatment:

Drug: Yuxintine

Yuxintine 300mg per day

Experimental group

Description:

Yuxintine 300mg oral, once a day, 6 weeks

Treatment:

Drug: Yuxintine

Yuxintine 400mg per day

Experimental group

Description:

Yuxintine 400mg oral, once a day, 6 weeks

Treatment:

Drug: Yuxintine

Placebo

Placebo Comparator group

Description:

Placebo oral, once a day, 6 weeks

Treatment:

Drug: Yuxintine