Posttraumatic Stress Disorder
Conditions
Interventions
Trade Name: Clonidin-ratiopharm® 75
Product Name: Clonidinhydrochlorid
Pharmaceutical Form: Capsule, hard
CAS Number: 4205-90-7
Current Sponsor code: Clonidinhydrochloride
Other descriptive name: CLON
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item CAPS-5 total score = 26 2. At least two nightmares a week, an intensity score = 2, with a CAPS-IV B2 (frequency and intensity for the last week) score = 5 3. Men and women between 18 and 65 years of age 4. Written informed consent 5. 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) 6. The patient is not breastfeeding 7. Women of child-bearing potential must have a negative urine or serum pregnancy test 8. All participants must use highly effective contraception 9. 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) 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 189 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Disturbances of cardiac impulse formation and conduction, for example sick sinus syndrome or atrioventricular block second and third degree 2. Bradycardia, with a heart rate less than 50 beats per minute 3. Current major depressive episode and a MADRS score > 34 4. The patient does have a known allergy, hypersensitivity or contraindication against clonidine, doxazosin, or other types of quinazolines 5. History of severe orthostatic hypotension 6. Benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones, hypotension (for benign prostate hyperplasia only) 7. Either overflow bladder or anuria with or without progressive renal insufficiency 8. Planned cataract surgery (risk of 'Intraoperative Floppy Iris Syndrome') 9. Intake of phosphodiesterase-5-inhibitors 10. Intake of methylphenidate 11. Severe hepatic impairment (ASAT or ALAT greater than two times normal) 12. Acute or unstable medical illness 13. Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection 14. Current or past malignant illness 15. The patient does have clinically significant abnormalities in 12-lead ECG 16. The patient does have clinically significant laboratory abnormalities 17. Epilepsy 18. Dementia 19. Current substance/alcohol use disorder (= 3 months) 20. Psychotic disorder 21. Bipolar disorder 22. Current anorexia nervosa 23. Acute suicidality (any suicidal ideation of type of 5 in the C-SSRS in the past month) 24. Intake of alpha adrenergic agents (Clonidine, doxazosin, or others) within 4 weeks prior to baseline (randomization) 25. Trauma-focused psychotherapy four weeks before the trial 26. Initiation of sleep medication 4 weeks prior to baseline 27. The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons 28. Patients, who may be dependent on the sponsor, the investigator or the trial sites 29. The patient is legally detained in an official institution 30. The patient did participated in other interventional trials during the 3 months before and at the time of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Secondary objectives of the study are to examine the efficacy of oral clonidine or doxazosin in reducing other PTSD-specific symptoms, general sleep parameters and depressive symptoms in patients with posttraumatic stress disorder.;Primary end point(s): Primary efficacy endpoint: 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 (10 weeks, visit 9). A lower score indicates less frequent and/or intense nightmares.;Timepoint(s) of evaluation of this end point: Timepoint of evaluation will be done after last Intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline of the frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0–8, at Visit 2 – Visit 8 2. Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week) at Visit 7 and Visit 9 3. Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI A) (PTSD related sleep symptoms) at Visit 7 and Visit 9 4. Change from baseline of the Montgomery Asberg Depression Inventory (MADRS) at Visit 7 and Visit 9 5. Weekly mean of change from baseline of the patients daily total sleep time (in minutes), sleep onset latency at night (in minutes), recuperation of night sleep (5-point Likert scale, 1 = very much; 5 = not at all), and time awake at night (in minutes), number of nightmares last night (0, 1, 3, 4 or more) and intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries during Visit 2 – Visit 9 6. Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5) at Visit 7 and Visit 9 7. Change from baseline of the Borderline Symptom List 23 (BSL-23) score at Visit 7 and Visit 9 8. Change from baseline of the Health-Related Quality of Life (EQ-5D) score at Visit 7 and Visit 9 9. Overall patient status measured by the Patient Global Impression of Change (PGIC) at Visit 7 and Visit 9 10. Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS) at Visit 7 and Visit 9 11. Change from baseline of the Pittsburgh Sleep Quality Index (PSQI) at Visit 7 and Visit 9 12. Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ) at Visit 7 and Visit 9 13. Responder analysis: proportion of patients showing improvement in nightmares (change from baseline) defined as decrease of CAPS-IV B2 = 50% assessed at the end of treatment (Visit 9) 14. Remit | — |
Countries
Germany
Contacts
Public ContactPrincipal Investigator
Charité – Universitätsmedizin Berlin
Outcome results
None listed