跳至主要内容
临床试验/NL-OMON37075
NL-OMON37075招募中3 期

An open label study with objective sleepregistration on the effects of Doxazosin as treatment for PTSD, especially for sleep disturbance - Doxazosin for PTSD With sleepregistration (DoPS).

Parnassia Bavo Groep (Den Haag)0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
20

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

年龄范围
12 至 99(—)

入选标准

  • - Good speaking and writing in Dutch
  • - PDS above 18
  • - CAPS recurrent distressing dreams item score above 5
  • - CAPS difficulty falling or staying asleep item above 5
  • - No medication except contraceptives or analgetics like paracetamol
  • - No alcohol more than two consumptions a day
  • - Medication use of psychotropics has stopped at least one month before entrance of the study
  • - If psychotherapy has not been started yet it will not be initiated during the trial; If started it will be paused for the period of the study. Medication with influence on sleep-EEG will not be started during the study period (paracetamol and contraceptives are allowed).

排除标准

  • Psychiatric:
  • - Lifetime schizophrenia,
  • - schizoaffective disorder,
  • - bipolar disorder,
  • - severe depressive disorder (MADRS > 34) (for screening: QIDS > 15)
  • - cognitive disorder,
  • - current delirium,
  • - substance use within 2 months of the study; alcohol is allowed if not more than 2 consumptions a day.
  • - severe psychiatric instability (including evidence of being actively suicidal or homicidal).
  • - any behavior which poses an immediate danger to patient or others.;Somatic:
  • - preexisting hypotension or (anamnestic) orthostatic hypotension
  • - hypertension unless stable with help of anti-hypertensive medication.
  • - Known for severe ischaemic heart disease
  • - disease with strong reduced functioning of the liver.
  • - Women of childbearing potential with either positive pregnancy test or refusal to use effective birth control method.
  • - Allergy or previous adverse reaction to doxazosin or other alpha-1 antagonist.
  • - Hypersensitivity to quinazolinderivates
  • - Known for hypertrophy of the prostate without treatment.
  • - Gastro-intestinal obstruction
  • - oesophageal obstruction
  • - overflow bladder or anuria with or without progressive renal insufficiency

研究者

发起方
Parnassia Bavo Groep (Den Haag)

相似试验

An open label study with objective sleepregistration... | 临床试验