CTRI/2017/11/010324暂停4 期
A Prospective, randomized, active-controlled, Comparative, Open-Label, parallel group, 2-arm, Multi-centric, Phase IV trial for evaluation of efficacy and safety of FDC of Amitriptyline and Chlordiazepoxide tablets of Wockhardt Limited versus Amitriptyline alone in management of depression with co-morbid anxiety.
Wockhardt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
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
- •Subject with all of the following would be included in the study:
- •1. Patients with clinical diagnosis of depression with co-morbid anxiety (Depression Score: More than or equal to 8 and anxiety Score: 0 â?? 56) on Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) respectively.
- •2. Patients or LAR who understand the nature of the trial and provide written informed consent for trial
- •3. Subjects who are willing to comply with protocol procedures
排除标准
- •Subject with any of the following would be excluded from the study:
- •1. Patients with proven hypersensitivity to any of the contents of study medication i.e. Amitriptyline and Chlordiazepoxide.
- •2. Patients who, in the investigatorâ??s opinion, pose a risk for suicide/suicidal tendency
- •3. Patients with history of neuroleptic malignant syndrome due to any tricyclic antidepressants
- •4. History of any neurological disease including but not limited to stroke, tumor, seizure disorder history of brain trauma, chronic infection or a dementing illness or any psychotic disorder including but not limited to schizophrenia, delusional disorder or organic brain syndrome.
- •5. Significant Hepatic and/ or Renal insufficiency
- •6. Patient with known history of or currently suffering from Cardiac arrhythmia or conduction abnormality including but not limited to sinus tachycardia and prolongation of conduction time (Screening QTcB or QTcF > 450 msec).
- •7. Patient with known history of urinary retention due to organic failure
- •8. Patient with history of Myocardial Infarction (MI) or is in acute recovery phase of MI.
- •9. Patient who used a monoamine oxidase inhibitor (MAOI) within 14 days prior to screening or are expected to need MAOI treatment at any time during this study
- •10. Patients who have received an antipsychotic or a benzodiazepine for at least 7 days prior to enrolment into the study
- •11. Pregnant or lactating females.
- •12. Patients who are alcoholics or having withdrawal symptoms of alcohol
- •13. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
研究者
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