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Early termination due to recruitment issues
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Clonidine | Experimental |
| |
| Arm Doxazosin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1,2,3,4,5,6 and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Roepke, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Tübingen | Tübingen | Germany | 72076 | Germany | ||
| Berlin St. Hedwig |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40764082 | Derived | 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. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| D017292 | Doxazosin |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Randomized controlled study (double-blind)
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| Doxazosin | 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 | Drug | All patients enrolled establish their individually tolerable dose by dose Titration. Dosage up to a maximum of 5 capsules. Using capsules of placebo. |
|
| 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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:
| 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) | 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)) | 10 weeks |
| Berlin |
| 10115 |
| Germany |
| Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie | Berlin | 12203 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Zentralinstitut für Seelische Gesundheit Mannheim | Mannheim | 86159 | Germany |
| D006571 |
| Heterocyclic Compounds |
| D011224 | Prazosin |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |