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临床试验/CTRI/2024/03/064593
CTRI/2024/03/064593尚未招募4 期

Comparative Effectiveness and Safety of Cariprazine and Lamotrigine in Patients of Bipolar Depression: A Prospective,Randomized,Open Label Study - Nil

A0 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
尚未招募
发起方
A

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

  • 18-65 years of age, of either sex, with a principal diagnosis of Bipolar Depression based on ICD-10 & BDRS Screening, after receiving a written informed consent
  • A physical examination, clinical laboratory and ECG with no significant clinical results

排除标准

  • 1. History or current diagnosis of various axis I disorders other than Bipolar I disorder, suicide risk as observed using MADRS scale, risk of injury to self or others, organic disorders or mental retardation
  • 2. Patients of Unipolar depression
  • 3. Patients with 4 or more mood episodes in the prior 12 months or any current psychiatric diagnoses, including personality disorders of significant severity to interfere with the study besides Bipolar I depression
  • 4.History of allergic or autoimmune disorders
  • 5.Any major cardiovascular, renal or hepatic comorbidities/diseases
  • 6. Psychotropic drug use except eszopiclone, zolpidem, zopiclone,Chloral hydrate or zaleplon, lorazepam or diphenhydramine, benztropine or propranolol
  • 7. Women of childbearing potential having positive UPT
  • 8. Patients not willing to give consent for the study

研究者

发起方
A

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