CTRI/2011/05/001719已完成3 期
An Open-Label, Randomized, Parallel Group, Prospective, Multicentre Clinical Trial for Evaluation of Efficacy and Safety of IN-ASTR-001 in Patients with Major Depressive Disorder.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients (≥ 18 yrs & ≤ 65 yrs) of MDD (according to DSM-IV-TR) with HDRS-17 score 20. And at least a score of 2 in the first item of the scale at screening and at baseline.
- •2.The subjects should have the score of at least 4 on CGI-S scale at the enrollment visit.
- •3.Female patients of childbearing potential- they are willing to use a medically valid and effective contraception throughout the study period.
- •4.Patients are willing to provide written informed consent
排除标准
- •1.Patients recording ≥20 % reduction in HDRS-17 score at the baseline (at the time of study treatment allocation) as against the same recorded at the time of screening.
- •2.History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder.
- •3.Patients not responding to the administration of an appropriate dose of two different earlier antidepressant treatments (including fluoxetine) for at least 4 weeks each, for the current and earlier episodes.
- •4.History of not responding to fluoxetine monotherapy for at least 4 weeks.
- •5.Pregnant woman and lactating mother.
- •6.Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
- •7.Patients with a high risk of suicidal behavior, scoring 3 on item No. 3 of HDRS-17 scale.
- •8.Concomitant psychotropic medication, including herbal preparations.
- •9.Neurologic disorders (dementia, seizure and stroke) or serious or uncontrolled diseases (hypertension, angina pectoris, myocardial infarction, diabetes mellitus etc.)
- •10.Hepatic insufficiency (SGOT/SGPT ≥ 2.0 x ULN) or Renal insufficiency (serum creatinine ≥ 1.5 x ULN)
- •11.Clinically significant abnormalities on physical examination or laboratory tests
- •12.Ongoing use of prohibited medications (Ex: TCA antidepressants, SSRIs, sedatives-hypnotics and melatonin & its other derivatives). Washout period according to drug?s half life is allowed before screening (at least 7 days). During washout period and initial 2 weeks of the study, if required only zolpidem (max 10 mg/day) is allowed.
- •13.Unsuitability for enrollment otherwise as decided by investigator.
- •14.Patients having participated in any type of clinical study within in the last one month of the screening date.
研究者
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