Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients
关键词
抽象
描述
To evaluate the improvement of the quality of life of antidepressant monotherapy on Chinese patients who meet DSM-5 criteria for the comorbidity of MDD and GAD. To monitor adverse events (AEs) and serious adverse events (SAEs) of antidepressant monotherapy
日期
最后验证: | 11/30/2013 |
首次提交: | 11/14/2013 |
提交的预估入学人数: | 12/09/2013 |
首次发布: | 12/15/2013 |
上次提交的更新: | 12/09/2013 |
最近更新发布: | 12/15/2013 |
实际学习开始日期: | 05/31/2013 |
预计主要完成日期: | 12/31/2013 |
预计完成日期: | 11/30/2014 |
状况或疾病
相
手臂组
臂 | 干预/治疗 |
---|---|
Western medicine venlafaxine or escitalopram | |
Chinese medcine Shuganjieyu capsule |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: 1. First episode outpatients in department of psychiatry, aged 18-65 years 2. Comorbidity of MDD and GAD according to DSM-5 criteria Hamilton Depression score (HAMD) of ≥18 at screening 3. HAMA≥14 at screening 4. Medically stable 5. Provision of written, informed consent. Exclusion Criteria: 1. Suicide ideation 2. Use antidepressants within at least 14 days before study begin 3. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence) 4. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse within 4 weeks prior to enrolment 5. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension, renal or hepatic dysfunction, cerebrovascular disease ) as judged by the investigator 6. Women in pregnancy or lactation 7. Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment. 8. Medical history with seizure disorder, except for febrile convulsion 9. Participation in another clinical study within 4 weeks (or longer time according to the local requirement) 10. Receive Electroconvulsive therapy (ECT) before study begin |
结果
主要结果指标
1. Evaluate the score of HAMD17 (Hamilton Depression Rating Scale) and HAMA (Hamilton Anxiety Rating Scale) of patients in each time between two groups [one year]
次要成果指标
1. Evaluate the symptom of depression, anxiety and quality of life in each time between two groups [one year]