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 Ltd6 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores.
研究概览
简要总结
Amitriptyline and Chlordiazepoxide is proven to be effective in management of depression with co-morbid anxiety.
This study is been designed to evaluate the efficacy and safety of FDC of Amitriptyline and Chlordiazepoxide tablets of Wockhardt limited Versus Amitriptyline alone in management of depression with co-morbid anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject with all of the following would be included in the study:
- •Patients with clinical diagnosis of depression with co-morbid anxiety (Depression Score: More than or equal to 8 and anxiety Score: 0 – 56) on Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) respectively.
- •Patients or LAR who understand the nature of the trial and provide written informed consent for trial
- •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:
- •Patients with proven hypersensitivity to any of the contents of study medication i.e. Amitriptyline and Chlordiazepoxide.
- •Patients who, in the investigator’s opinion, pose a risk for suicide/suicidal tendency
- •Patients with history of neuroleptic malignant syndrome due to any tricyclic antidepressants
- •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.
- •Significant Hepatic and/ or Renal insufficiency
- •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).
- •Patient with known history of urinary retention due to organic failure
- •Patient with history of Myocardial Infarction (MI) or is in acute recovery phase of MI.
- •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
- •Patients who have received an antipsychotic or a benzodiazepine for at least 7 days prior to enrolment into the study
- •Pregnant or lactating females.
- •Patients who are alcoholics or having withdrawal symptoms of alcohol 13.
结局指标
主要结局
Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores.
时间窗: At end of 45 days of therapy.
次要结局
- Mean change in Depression and anxiety scores from baseline using Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A)(At end of 45 days of therapy)
- Incidence of adverse events (AEs), serious adverse events (SAEs), abnormal laboratory values, Clinical findings(Throughout the treatment period)
研究者
研究点 (6)
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