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Status:

SUSPENDED

Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin

Lead Sponsor:

Charite University, Berlin, Germany

Collaborating Sponsors:

German Federal Ministry of Education and Research

Conditions:

Posttraumatic Stress Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief 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 grea...

Eligibility Criteria

Inclusion

  • 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).

Exclusion

  • 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
  • Epilepsy
  • Dementia
  • 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

Key Trial Info

Start Date :

June 17 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2026

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT05360953

Start Date

June 17 2022

End Date

July 31 2026

Last Update

August 13 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Universitätsklinikum Tübingen

Tübingen, Germany, Germany, 72076

2

Berlin St. Hedwig

Berlin, Germany, 10115

3

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie

Berlin, Germany, 12203

4

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany, 20246