Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin

NCT ID: NCT05360953

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-17
• Study Completion Date: 2026-07-31

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 greater extent than placebo over a ten week intervention phase in a parallel group design.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm Clonidine

Group Type: EXPERIMENTAL

Clonidine

Intervention Type: DRUG

All patients enrolled establish their individually tolerable dose by dose Titration. Dosage up to a maximum of 0.375 clonidine. Using capsules of 0,075 mg clonidine.

Arm Doxazosin

Group Type: EXPERIMENTAL

Doxazosin

Intervention Type: DRUG

All patients enrolled establish their individually tolerable dose by dose. Dosage up to a maximum of 10 mg doxazosin. Using capsules of 2 mg doxazosin.

Titration.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

All patients enrolled establish their individually tolerable dose by dose Titration. Dosage up to a maximum of 5 capsules. Using capsules of placebo.

Interventions

Clonidine

All patients enrolled establish their individually tolerable dose by dose Titration. Dosage up to a maximum of 0.375 clonidine. Using capsules of 0,075 mg clonidine.

Intervention Type: DRUG

Doxazosin

All patients enrolled establish their individually tolerable dose by dose. Dosage up to a maximum of 10 mg doxazosin. Using capsules of 2 mg doxazosin.

Titration.

Intervention Type: DRUG

Placebo

All patients enrolled establish their individually tolerable dose by dose Titration. Dosage up to a maximum of 5 capsules. Using capsules of placebo.

Intervention Type: DRUG

Eligibility 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).

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Stefan Roepke

Prof. Dr. Stefan Roepke, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Roepke, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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

Countries

Germany

References

Roepke S, Schoofs N, Priebe K, Wuelfing F, Roehle R, Maslahati T, Stieglbauer K, Biedermann S, Schaefer I, Gallinat J, Ethofer T, Fallgatter AJ, Hanewald B, Mulert C, Schmahl C, Otte C, Koglin S. Treating nightmares in post-traumatic stress disorder with the alpha-adrenergic agents clonidine and doxazosin: protocol for a phase II randomised, double-blind, placebo-controlled parallel-group study (ClonDoTrial). BMJ Open. 2025 Aug 5;15(8):e098161. doi: 10.1136/bmjopen-2024-098161.

Reference Type: DERIVED

PMID: 40764082 (View on PubMed)

Other Identifiers

ClonDO

Identifier Type: -

Identifier Source: org_study_id