Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin (NCT05360953) | Clinical Trial Compass
SuspendedPhase 2
Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin
Stopped: Early termination due to recruitment issues
Germany53 participantsStarted 2022-06-17
Plain-language summary
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.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion criteria
ā. Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item CAPS-5 total score ā„ 26
ā. At least two nightmares a week, an intensity score ā„ 2, with a CAPS-IV B2 (frequency and intensity for the last week) score ā„ 5
ā. Men and women between 18 and 65 years of age
ā. Written informed consent
ā. 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)
ā. The patient is not breastfeeding
ā. Women of child-bearing potential must have a negative urine or serum pregnancy test
ā. All participants must use highly effective contraception
Exclusion criteria
ā. Disturbances of cardiac impulse formation and conduction, for example sick sinus syndrome or atrioventricular block second and third degree
ā. Bradycardia, with a heart rate less than 50 beats per minute
ā. Current major depressive episode and a MADRS score \> 34
ā. The patient does have a known allergy, hypersensitivity or contraindication against clonidine, doxazosin, or other types of quinazolines