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Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin

Treating Nightmares in Posttraumatic Stress Disorder With the α-adrenergic Agents Clonidine and Doxazosin: A Randomized-Controlled Feasibility Study (ClonDoTrial)

NCT05360953•Charite University, Berlin, Germany

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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).

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
+20 more criteria

Locations (5)

Universitätsklinikum Tübingen

Tübingen, Germany, Germany

Berlin St. Hedwig

Berlin, Germany

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

Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, Germany

Key Dates

Start Date

June 17, 2022

Primary Completion Date

August 8, 2025

Completion Date

July 31, 2026

Last Updated

August 13, 2025

Enrollment

ACTUAL participants

Conditions

Posttraumatic Stress Disorder

Interventions

Clonidine

DRUG

Doxazosin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin

Inclusion Criteria

Exclusion Criteria

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