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
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