跳至主要内容
临床试验/EUCTR2020-002787-32-GB
EUCTR2020-002787-32-GB进行中(未招募)1 期

Antidepressant for the prevention of DEPression following first episode Psychosis trial - ADEPP

niversity of Birmingham0 个研究点目标入组 508 人开始时间: 2020年9月16日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
508

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

  • Diagnosis of first-episode psychosis (FEP).
  • Within 3 months of initial treatment for FEP (as defined by onset of care provision by an Early Intervention Team).
  • Positive and Negative Syndrome Scale (PANSS) individual positive item scores all = 4.
  • Sufficiently recovered from acute psychotic episode with capacity to consent.
  • Aged 18-35 years.
  • Currently prescribed antipsychotic medication at stable dose.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 508
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Current moderate or severe depression (as indicated by a Calgary Depression for
  • Schizophrenia Scale (CDSS) score of >7).
  • Currently prescribed antidepressant medication (or within 2 weeks of stopping if a Monoamine Oxidaise Inhibitor)
  • Previous history of mania.
  • Contraindications to selective serotonin reuptake inhibitors (SSRI) antidepressant treatment (e.g. recurrent thrombotic illness, previous adverse reaction, confirmed pregnancy, although risk in pregnancy is low, prescribed pimozide).
  • Serious medical or neurological illness (as identified by the treating consultant psychiatrist).
  • Electrocardiogram (ECG): QTc interval >450 as measured in the last 12 months.
  • Aged below 18 years
  • Aged over 35 years

研究者

相似试验