Comparison of Yuxintine With Placebo in Treatment of MDD

NCT02395263 | Unknown Phase 2 DMC

• 2 other identifiers: Yuxintine Capsule-MDD-Ⅱb2012ZX09303-003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• The change of total score from baseline in MADRS scale

  6 weeks

Secondary Outcomes (8)

• clinical response rate according to MADRS

  6 weeks

• clinical remission rate according to MADRS

  6 weeks

• CGI(CGI-S,CGI-I)

  6 weeks

• The change of total score from baseline in HAMD scale

  6 weeks

• decreasing rate from baseline in HAMD scale

  6 weeks

Other Outcomes (6)

• vital sign

  6 weeks

• The Arizona Sexual Experience Scale (ASEX)

  6 weeks

• laboratory examination

  6 weeks

Study Arms (4)

Yuxintine 200mg per day

EXPERIMENTAL

Yuxintine 200mg oral, once a day, 6 weeks

Drug: Yuxintine

Yuxintine 300mg per day

EXPERIMENTAL

Yuxintine 300mg oral, once a day, 6 weeks

Drug: Yuxintine

Yuxintine 400mg per day

EXPERIMENTAL

Yuxintine 400mg oral, once a day, 6 weeks

Drug: Yuxintine

Placebo

PLACEBO COMPARATOR

Placebo oral, once a day, 6 weeks

Drug: Yuxintine

Interventions

Yuxintine DRUG

Placebo; Yuxintine 200mg per day; Yuxintine 300mg per day; Yuxintine 400mg per day

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(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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Shanghai Innovative Research Center of Traditional Chinese Medicine: collaborator

Study Sites (10)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100083, China

Location

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, 100096, China

Location

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 404000, China

Location

Shenzhen Mental Health Center

Shenzhen, Guangdong, 518020, China

Location

the People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Location

Affiliated Hospital of Guiyang Medical College

Guiyang, Guizhou, 550004, China

Location

Hebei Mental Health Center

Shijiazhuang, Hebei, 071000, China

Location

Hunan Brain Hospital

Changsha, Hunan, 410007, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, 300074, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Huafang LI, MD PhD

CONTACT

86-21-34773128; lhlh_5@163.com

Yifeng SHEN, MD PhD

CONTACT

86-21-34773215; shenyifeng@yahoo.com

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: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 23, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

CN (10)