Posttraumatic Stress DisorderPhase 2NCT05360953
Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin
A Phase 2 study testing Clonidine and Doxazosin in people with Posttraumatic Stress Disorder, run by Charite University, Berlin, Germany at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Clonidine and Doxazosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 5 sitesGermany
- Study dates
- 17 Jun 2022to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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)
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Berlin St. Hedwig
Berlin, 10115
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie
Berlin, 12203
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Zentralinstitut für Seelische Gesundheit Mannheim
Mannheim, 86159
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
About this study
Official title: Treating Nightmares in Posttraumatic Stress Disorder With the α-adrenergic Agents Clonidine and Doxazosin: A Randomized-Controlled Feasibility Study (ClonDoTrial)
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
- Being tested
- Clonidine, Doxazosin, Placebo
- Keywords
- Nightmares, Posttraumatic Stress Disorder, Clonidine, Doxazosin
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
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.
DoxazosinDrug
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.
PlaceboDrug
All patients enrolled establish their individually tolerable dose by dose Titration. Dosage up to a maximum of 5 capsules. Using capsules of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Arm Clonidine | Experimental | Not described Receives: Drug: Clonidine |
| Arm Doxazosin | Experimental | Not described Receives: Drug: Doxazosin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of frequency and intensity of nightmares
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. A lower score indicates less frequent and/or intense nightmares.
Measured: 10 weeks
Secondary outcomes (19)
Change of frequency and intensity of nightmares
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. A lower score indicates less frequent and/or intense nightmares.
Measured: 1,2,3,4,5,6 and 8 weeks
Change from baseline of the CLINICIAN-ADMINISTERED PTSD SCALE FOR DSM-5 (CAPS-5) total score
Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week) (minimum value = 0; maximum value = 80; higher scores indicate higher PTSD symptom severity)
Measured: 6 and 10 weeks
Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD
Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI A) (PTSD related sleep symptoms); (score = 0-21 point, 0 = no difficulty; 21 = severe difficulty in all areas)
Measured: 6 and 10 weeks
Change from baseline of the -Montgomery Asberg Depression Rating Scale (MDRS)
Change from baseline of the MADRS (scores: 0 - 60; 0 - 6 = no depression; 7 - 19 = light depression; 20 - 34 = moderate depression; > 34 severe depression)
Measured: 6 and 10 weeks
Weekly mean of change from baseline of daily total sleep time
Weekly mean of change from baseline of the patients daily total sleep time (in minutes), assessed with sleep diaries
Measured: during 10 weeks
Weekly mean of change from baseline of the patients sleep onset latency at night (in minutes), assessed with sleep diaries
Weekly mean of change from baseline of the patients sleep onset latency at night (in minutes), assessed with sleep diaries
Measured: during 10 weeks
Weekly mean of change from baseline of the patients recuperation of night sleep
Weekly mean of change from baseline of the patients recuperation of night sleep (5-point Likert scale, 1 = very much; 5
= not at all), assessed with sleep diaries
Measured: during 10 weeks
Weekly mean of change from baseline of the patients time awake at night
Weekly mean of change from baseline of the patients time awake at night (in minutes), assessed with sleep diaries
Measured: during 10 weeks
Weekly mean of change from baseline of the patients number of nightmares last night
Weekly mean of change from baseline of the patients number of nightmares last night (0, 1, 3, 4 or more) assessed with sleep diaries
Measured: during 10 weeks
Weekly mean of change from baseline of the patients intensity of nightmares
Weekly mean of change from baseline of the patients intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries
Measured: during 10 weeks
Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5
Change from baseline of PCL-5 PTSD Checklist for DSM-5; Score can range from 0-80 (higher scores indicate a higher PTSD symptom severity) Score (0 - 80; higher scores indicating higher chance of a possible PTSD diagnosis)
Measured: 6 and 10 weeks
Change from baseline of the Borderline Symptom List 23 (BSL-23)
Change from baseline of the BSL-23 score (Scores can range from 0 to 92; higher scores indicate higher Borderline symptom severity) Scores: 0 - 4 (0 = no Borderline Symptoms; 4 = severe borderline symptoms)
Measured: 6 and 10 weeks
Change from baseline of the Health-Related Quality of Life (EQ-5D)
Change from baseline of the EQ-5D score (score can range from 0-100; with higher scores indicating a better Health Related Quality of Life) Scores = 1-5 (1 = no problems; 5 = extreme problems)
Measured: 6 and 10 weeks
Overall patients status measured by the Patient Global Impression of Change (PGIC)
Overall patients status measured by the PGIC (Scores can range from 0 - 7; with higher scores indicating higher improvement) score: 0 - 7 (0 = disease deterioration; 7 = disease improvement)
Measured: 6 and 10 weeks
Change from baseline of the Social and Occupational Functioning Assessment Scale
Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS); Scores can range from 1 - 100, with higher scores indicating better social and occupational functioning
Measured: 6 and 10 weeks
Change from baseline of the Pittsburgh Sleep Quality Index (PSQI)
Change from baseline of the PSQI; Scores can range from 0 to 21, with higher scores indicating lower sleep quality Scores : 0 - 21, lower scores denote a healthier sleep quality
Measured: 6 and 10 weeks
Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ)
Change from baseline of symptoms of ITQ, dimensional scores can range from 0 - 24, with higher scores indicating highter PTSD symptom severity
Categorical Scoring:
For PTSD items, endorsement of a symptom or functional impairment item is defined as a score of 2 or greater.
The diagnosis of PTSD is indicated based on the following criteria:
- Question 1 or 2 = one or more items endorsed (re-experiencing)
- Question 3 or 4 = one or more items endorsed (avoidance)
- Question 5 or 6 = one or more items endorsed (sense of current threat)
- Question 7, 8 or 9 = one or more items endorsed (PTSD functional impairment)
Measured: 6 and 10 weeks
Responder analysis: proportion of patients showing improvement in nightmares
Responder analysis: proportion of patients showing improvement in nightmares (change from baseline) defined as decrease of CLINICIAN-ADMINISTERED PTSD SCALE FOR DSM-IV (CAPS-IV B2) ≥50% assessed at the end of treatment
Score: 0 - 8 (higher scores indicate higher frequency and severity of nightmares)
Measured: 10 weeks
Remitter analysis: proportion of patients showing full remission of nightmares
Remitter analysis: proportion of patients showing full remission of nightmares defined as CLINICIAN-ADMINISTERED PTSD SCALE FOR DSM-IV (CAPS-IV B2) = 0, assessed at the end of treatment; 0 = no nightmares (score 0 - 8; higher scores indicate higher frequency and severity of nightmares))
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start17 Jun 2022
- Primary completion8 Aug 2025
- Study completion31 Jul 2026 (estimated)
Why it stopped: Early termination due to recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study (double-blind)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Stefan Roepke, Charite University, Berlin, Germany
- Investigators
- Stefan Roepke, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360953
- Sponsor's protocol ID
- ClonDO
- Status last verified
- Jan 2025
- First submitted
- 29 Apr 2022
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40764082
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Nightmares in Posttraumatic Stress Disorder With the α-adrenergic Agents Clonidine and Doxazosin: A Randomized-Controlled Feasibility Study (ClonDoTrial)
- ClinicalTrials.gov ID
- NCT05360953
- Acronym / sponsor ID
- ClonDO
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Nightmares, Posttraumatic Stress Disorder, Clonidine, Doxazosin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Early termination due to recruitment issues
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled study (double-blind)
| Arm | Type | Receives |
|---|---|---|
| Arm Clonidine | Experimental | Drug: Clonidine |
| Arm Doxazosin | Experimental | Drug: Doxazosin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClonidineAll 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. | Drug | Arm Clonidine |
| DoxazosinAll 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. | Drug | Arm Doxazosin |
| PlaceboAll patients enrolled establish their individually tolerable dose by dose Titration. Dosage up to a maximum of 5 capsules. Using capsules of placebo. | Drug | Placebo |
Primary outcome
Change of frequency and intensity of nightmares
Time frame: 10 weeks
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. A lower score indicates less frequent and/or intense nightmares.
19 secondary outcomes
Change of frequency and intensity of nightmares
Time frame: 1,2,3,4,5,6 and 8 weeks
Change from baseline of the CLINICIAN-ADMINISTERED PTSD SCALE FOR DSM-5 (CAPS-5) total score
Time frame: 6 and 10 weeks
Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD
Time frame: 6 and 10 weeks
Change from baseline of the -Montgomery Asberg Depression Rating Scale (MDRS)
Time frame: 6 and 10 weeks
Weekly mean of change from baseline of daily total sleep time
Time frame: during 10 weeks
Weekly mean of change from baseline of the patients sleep onset latency at night (in minutes), assessed with sleep diaries
Time frame: during 10 weeks
Weekly mean of change from baseline of the patients recuperation of night sleep
Time frame: during 10 weeks
Weekly mean of change from baseline of the patients time awake at night
Time frame: during 10 weeks
Weekly mean of change from baseline of the patients number of nightmares last night
Time frame: during 10 weeks
Weekly mean of change from baseline of the patients intensity of nightmares
Time frame: during 10 weeks
Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5
Time frame: 6 and 10 weeks
Change from baseline of the Borderline Symptom List 23 (BSL-23)
Time frame: 6 and 10 weeks
Change from baseline of the Health-Related Quality of Life (EQ-5D)
Time frame: 6 and 10 weeks
Overall patients status measured by the Patient Global Impression of Change (PGIC)
Time frame: 6 and 10 weeks
Change from baseline of the Social and Occupational Functioning Assessment Scale
Time frame: 6 and 10 weeks
Change from baseline of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 and 10 weeks
Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ)
Time frame: 6 and 10 weeks
Responder analysis: proportion of patients showing improvement in nightmares
Time frame: 10 weeks
Remitter analysis: proportion of patients showing full remission of nightmares
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 40764082Roepke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Roepke, MD principal investigator
Charite University, Berlin, Germany
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonidine and Doxazosin in people with Posttraumatic Stress Disorder, run by Charite University, Berlin, Germany at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of frequency and intensity of nightmares (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05360953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.