跳至主要内容
临床试验/EUCTR2009-011253-40-IT
EUCTR2009-011253-40-IT进行中(未招募)不适用

Paroxetine or Quetiapine in Addition to Mood Stabilizers in Bipolar Depression - ND

AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO0 个研究点开始时间: 2009年4月16日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Age ≥ 18 years
  • 2. Read understood and signed the informed consent
  • 3. Diagnosis of Bipolar Disorder, Major Depressive Episode diagnosed by means of MINI 5.0.0.
  • 4. Treatment with lithium or valproate in previous 2 months, with lithium levels 0.6-1.2 mEq/L or valproate levels 50-130 ug/ml at baseline
  • 5.HAM-D ≥ 18
  • 6.YMRS ≤ 12
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Severe or unstable medical conditions
  • 2. Pregnancy or non-utilization of contraceptives;
  • 3. Suicide ideation or HAMD item 3 ≥ 3
  • 4. Rapid cycling bipolar disorder
  • 5. Another principal DSM-IV TR Axis I disorder
  • 6. Non response or intollerance to paroxetine or quetiapine

研究者

发起方
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

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