CTRI/2008/091/000197已完成2 期
A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group,Flexible Dose Titration, Add-On Study of TC-5214 2 - 8 mg in the Treatment of MajorDepressive Disorder with Subjects who are Partial Responders or Non-Responders toCitalopram Therapy
Targacept0 个研究点目标入组 270 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
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. Male or female subjects aged 18 to70 years
- •2. Diagnosis of major depressive disorder (MDD) according to DSM IV and confirmed via MINI diagnostic scale
- •3. No more than 1 prior antidepressant course of treatment before trial entry for the current episode of depression.
- •4. Able to give written informed consent.
- •5. MADRS score greater than 27.
- •6. CGI S score greater than or equal to 4.
- •7. No clinically significant abnormality on physical examination, vital signs, ECG or laboratory tests (biochemical, hematological, urinary) at screening. Screening may be extended to repeat any clinically significant laboratory value. Any clinically significant which can be medically justified, is stable and will not place the subject at undue risk maybe allowed after discussion and approval by the Targacept Medical Monitor.
- •8. Women of child bearing potential must: a) have a negative urine pregnancy test, b) not be nursing, and c) be willing to use acceptable methods of contraception throughout the study period.
排除标准
- •1.Any co morbid psychiatric illness confirmed by MINI diagnostic scale, especially bipolar disorder, schizophrenia, dementia, or PTSD
- •2. Subjects with significant suicidal risk upon clinical assessment utilizing the M.I.N.I.
- •3. History of alcohol or drug abuse over the last 6 months
- •4. History of seizures or seizure disorders
- •5. Any other severe progressive and uncontrolled medical condition
- •6. For other controlled medical conditions, medication to be unchanged over the 2 months preceding screening, or else the subject will be excluded
- •7. Subjects with Glaucoma, Kidney Disease or Heart Disease
- •8. Known hypersensitivity to mecamylamine
- •9. Other investigational drug in previous 30 days
- •10. Screening QTcB or QTcF > 450 msec
- •11. Prior use of citalopram or escitalopram for the current episode of MDD
研究者
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