BridgeMD
Treating Nightmares in Posttraumatic Stress Disorder with the α-adrenergic Agents Clonidine and Doxazosin: A Randomized-Controlled Feasibility Study - ClonDoTrial
EU CTIS ID: 2024-517537-40-00
What this study is testing
To examine whether oral clonidine (0.075-0.375 mg) or doxazosin (1-10 mg) reduces nightmares to a greater extent than placebo in patients with posttraumatic stress disorder.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 CAPSIV 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
You likely can't join if
- Disturbances of cardiac impulse formation and conduction, for example sick sinus syndrome or atrioventricular block second and third degree
- 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
See the full eligibility criteria
- 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 CAPSIV 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)
- Disturbances of cardiac impulse formation and conduction, for example sick sinus syndrome or atrioventricular block second and third degree
- 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
- Epilepsy
- Dementia
- Current substance/alcohol use disorder (≤ 3 months)
- Bradycardia, with a heart rate less than 50 beats per minute
- 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
- Current major depressive episode and a MADRS score > 34
- The patient did participated in other interventional trials during the 3 months before and at the time of this trial
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.