Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bionorica SE | INDUSTRY |
Not provided
Not provided
Not provided
This randomized controlled exploratory phase II trial will test the hypothesis that oral dronabinol improves nightmares (primary outcome) and other PTSD symptoms (secondary outcomes) to a greater extent than placebo over a ten week intervention phase in a parallel group design.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BX-1 (dronabinol) | Experimental | BX-1 |
|
| Placebo | Placebo Comparator | Placebo of BX-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BX-1 | Drug | BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and intensity of nightmares | Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. A lower score indicates less frequent and/or intense nightmares. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of the frequency and intensity of nightmares | Change from baseline of the frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. | 1, 2, 3, 4,6 and 8 weeks |
| Change from baseline of the CAPS-5 total score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefan Roepke, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin St. Hedwig | Berlin | 10115 | Germany | |||
| Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37147642 | Derived | Roepke S, Schoofs N, Priebe K, Wulfing F, Schmahl C, Rohle R, Zahringer J, Lotter T, Otte C, Koglin S. Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial). BMC Psychiatry. 2023 May 5;23(1):319. doi: 10.1186/s12888-023-04818-5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Randomized controlled study (double-blind)
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo of BX-1, oral solution |
|
Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week) |
| 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) | 6 and 10 weeks |
| Change from baseline of the Montgomery-Åsberg Depression Rating Scale | Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms) | 4 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 | 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 PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5) | 6 and 10 weeks |
| Change from baseline of the Borderline Symptom List 23 | Change from baseline of the Borderline Symptom List 23 (BSL-23) score | 6 and 10 weeks |
| Change from baseline of the Health-Related Quality of Life | Change from baseline of the Health-Related Quality of Life (EQ-5D) score | 6 and 10 weeks |
| Overall patients status measured by the Patient Global Impression of Change | Overall patients status measured by the Patient Global Impression of Change (PGIC) | 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) | 6 and 10 weeks |
| Change from baseline of the Pittsburgh Sleep Quality Index | Change from baseline of the Pittsburgh Sleep Quality Index (PSQI) | 6 and 10 weeks |
| Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire | Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ) | 6 and 10 weeks |
| Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist | Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist (MWC) | 6 and 10 weeks and Follow- Up Visit 9 |
| 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 CAPS-IV B2 ≥50% assessed at the end of treatment | 10 weeks |
| Remitter analysis: proportion of patients showing full remission of nightmares | Remitter analysis: proportion of patients showing full remission of nightmares defined as CAPS-IV B2 = 0, assessed at the end of treatment | 10 weeks |
| Berlin |
| 12203 |
| Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Zentralinstitut für Seelische Gesundheit Mannheim | Mannheim | 86159 | Germany |