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

ParnassiaBavoGroup0 个研究点开始时间: 2012年8月30日最近更新: 2012年12月10日

适应症

试验速览

暂无简介。

•- 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).
•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 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.
•-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

发起方

ParnassiaBavoGroup