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临床试验/NCT05360953
NCT05360953暂停2 期

Treating Nightmares in Posttraumatic Stress Disorder With the α-adrenergic Agents Clonidine and Doxazosin: A Randomized-Controlled Feasibility Study (ClonDoTrial)

Charite University, Berlin, Germany5 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2022年6月17日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
暂停
入组人数
53
试验地点
5
主要终点
Change of frequency and intensity of nightmares
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This randomized controlled trial will test the hypothesis that oral Clonidine or Doxazosin improves nightmares (primary outcome), other PTSD symptoms and psychopathology (secondary outcomes) to a greater extent than placebo over a ten week intervention phase in a parallel group design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item CAPS-5 total score ≥ 26
  • •At least two nightmares a week, an intensity score ≥ 2, with a CAPS-IV B2 (frequency and intensity for the last week) score ≥ 5
  • •Men and women between 18 and 65 years of age
  • •Written informed consent
  • •The patient has the capacity to give consent (He/she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention)
  • •The patient is not breastfeeding
  • •Women of child-bearing potential must have a negative urine or serum pregnancy test
  • •All participants must use highly effective contraception
  • •The patient received stable pharmacological medication for at least 4 weeks or at least five times the value of a elimination half-life prior to study baseline (any changes in medication dose or frequency of therapy must be answered with no).

排除标准

  • •Disturbances of cardiac impulse formation and conduction, for example sick sinus syndrome or atrioventricular block second and third degree
  • •Bradycardia, with a heart rate less than 50 beats per minute
  • •Current major depressive episode and a MADRS score > 34
  • •The patient does have a known allergy, hypersensitivity or contraindication against clonidine, doxazosin, or other types of quinazolines
  • •History of severe orthostatic hypotension
  • •Benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones, hypotension (for benign prostate hyperplasia only)
  • •Either overflow bladder or anuria with or without progressive renal insufficiency
  • •Planned cataract surgery (risk of 'Intraoperative Floppy Iris Syndrome')
  • •Intake of phosphodiesterase-5-inhibitors
  • •Intake of methylphenidate
  • •Severe hepatic impairment (ASAT or ALAT greater than two times normal)
  • •Acute or unstable medical illness
  • •Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection
  • •Current or past malignant illness
  • •The patient does have clinically significant abnormalities in 12-lead ECG
  • •The patient does have clinically significant laboratory abnormalities
  • •Current substance/alcohol use disorder (≤ 3 months)
  • •Psychotic disorder
  • •Bipolar disorder
  • •Current anorexia nervosa
  • •Acute suicidality (any suicidal ideation of type of 5 in the C-SSRS in the past month)
  • •Intake of alpha adrenergic agents (Clonidine, doxazosin, or others) within 4 weeks prior to baseline (randomization)
  • •Trauma-focused psychotherapy four weeks before the trial
  • •Initiation of sleep medication 4 weeks prior to baseline
  • •The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons
  • •Patients, who may be dependent on the sponsor, the investigator or the trial sites
  • •The patient is legally detained in an official institution
  • •The patient did participated in other interventional trials during the 3 months before and at the time of this trial

研究组 & 干预措施

Arm Clonidine

Experimental

干预措施: Clonidine (Drug)

Arm Doxazosin

Experimental

干预措施: Doxazosin (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Change of frequency and intensity of nightmares

时间窗: 10 weeks

Change of Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8, from baseline until directly after last intervention. A lower score indicates less frequent and/or intense nightmares.

次要结局

  • Change of frequency and intensity of nightmares(1,2,3,4,5,6 and 8 weeks)
  • Change from baseline of the CLINICIAN-ADMINISTERED PTSD SCALE FOR DSM-5 (CAPS-5) total score(6 and 10 weeks)
  • Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD(6 and 10 weeks)
  • Change from baseline of the -Montgomery Asberg Depression Rating Scale (MDRS)(6 and 10 weeks)
  • Weekly mean of change from baseline of daily total sleep time(during 10 weeks)
  • Weekly mean of change from baseline of the patients sleep onset latency at night (in minutes), assessed with sleep diaries(during 10 weeks)
  • Weekly mean of change from baseline of the patients recuperation of night sleep(during 10 weeks)
  • Weekly mean of change from baseline of the patients time awake at night(during 10 weeks)
  • Weekly mean of change from baseline of the patients number of nightmares last night(during 10 weeks)
  • Weekly mean of change from baseline of the patients intensity of nightmares(during 10 weeks)
  • Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5(6 and 10 weeks)
  • Change from baseline of the Borderline Symptom List 23 (BSL-23)(6 and 10 weeks)
  • Change from baseline of the Health-Related Quality of Life (EQ-5D)(6 and 10 weeks)
  • Overall patients status measured by the Patient Global Impression of Change (PGIC)(6 and 10 weeks)
  • Change from baseline of the Social and Occupational Functioning Assessment Scale(6 and 10 weeks)
  • Change from baseline of the Pittsburgh Sleep Quality Index (PSQI)(6 and 10 weeks)
  • Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ)(6 and 10 weeks)
  • Responder analysis: proportion of patients showing improvement in nightmares(10 weeks)
  • Remitter analysis: proportion of patients showing full remission of nightmares(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Roepke

Prof. Dr. Stefan Roepke, MD

Charite University, Berlin, Germany

研究点 (5)

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