CTRI/2020/07/026583已完成4 期
An open Label,multicentre Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in Subjects with Major Depressive Disorder with Associated Anxiety in Regular Practice
Macsur Pharmaa I Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Willing and able to sign informed consent form. Written informed consent must be obtained before any assessment is performed.
- •2. Male and female subjects of aged 18 years to 75 years.
- •3. NaÃ?¯ve patients suffering from MDD with associated anxiety for at least 10 to 12 weeks as defined by DSM IV for at least 2 weeks.
- •4. Newly prescribed with Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg as per the investigators discretion.
排除标准
- •1. Hypersensitivity to Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg or any excipients.
- •2. Should not be suffering from any other psychiatric illness or any other chronic disease which would interfere with trial assessments.
- •3. Known contraindication for the use of Amitriptyline or Chlordiazepoxide.
- •4. any other treatments such as SSRIs, other antidepressants, thienodiazepines, benzodiazepines, barbiturates, or Ã?²-blockers potentially resulting in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication.
- •5. any medical (eg, cardiac, liver, renal, endocrinologic, neoplastic, pulmonary) or neurologic (eg, bipolar disorder, schizophrenia) disease and other clinical conditions.
- •6. A history of drug or alcohol abuse within the past 6 months.
- •7. Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study.
- •8. Female who is pregnant, nursing, or of child-bearing potential.
研究者
相似试验
已完成
4 期
This is a postmarketing surveillance to determine the efficacy and safety of 0.05 % Cyclosporine ophthalmic micro-emulsion for the treatment of Moderate to Severe Dry eye diseaseCTRI/2010/091/000095Cipla Ltd36
已完成
4 期
Study to Monitor the Safety and Efficacy of Combination Therapy of Desvenlafaxine Succinate Equal to Desvenlafaxine 100mg/50mg and Clonazepam 0.5 mg/0.5mg uncoated bilayered tablet in Major Depressive Disorder with Co-Morbid AnxietyCTRI/2021/04/033076GKM New Pharma200
已完成
4 期
Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in Subjects with Major Depressive Disorder with Associated AnxietyCTRI/2020/08/026974Macsur Pharmaa I Pvt Ltd200
已完成
4 期
A study to evaluate the safety and effect of Ropin Heavy® injection for spinal anaesthesia in adult subjectsCTRI/2022/03/040917eon Laboratories Ltd
招募中
4 期
A study of stempeucel® in patients with critical limb ischemia due to occlusive inflammatory condition of arteries and veinsCTRI/2018/02/011839Stempeutics Research Pvt Ltd