Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin

Who can take part

• 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)

Who cannot take part

• Benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones, hypotension (for benign prostate hyperplasia only)
• Intake of phosphodiesterase-5-inhibitors
• 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 did participated in other interventional trials during the 3 months before and at the time of this trial
• 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
• The patient does have a known allergy, hypersensitivity or contraindication against clonidine, doxazosin, or other types of quinazolines
• History of severe orthostatic hypotension
• Either overflow bladder or anuria with or without progressive renal insufficiency
• Planned cataract surgery (risk of 'Intraoperative Floppy Iris Syndrome')
• 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
• Epilepsy
• Dementia
• Current substance/alcohol use disorder (≤ 3 months)
• Psychotic disorder
• Bipolar disorder
• The patient does have clinically significant laboratory abnormalities
• Current major depressive episode and a MADRS score > 34
• Intake of methylphenidate
• The patient does have clinically significant abnormalities in 12-lead ECG
• Current anorexia nervosa
• Acute suicidality (any suicidal ideation of type of 5 in the C-SSRS in the past month)
• 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