[Cannabinoid Drugs in the Treatment of Psychiatric Disorders - Data from the German Federal Institute for Drugs and Medical Devices]. / Cannabisarzneimittel in der Behandlung psychischer Störungen ­ Befunde aus der Cannabis-Begleiterhebung des Bundesinstituts für Arzneimittel und Medizinprodukte.

BACKGROUND: Since 2017 physicians in Germany can prescribe cannabis based medicines or medical cannabis with subsequent funding by the statutory health insurance system. METHODS: Physicians prescribing cannabinoid drugs were legally required to take part in a survey conducted by the Federal Institute for Drugs and Medical Devices. This study analyses data from 16.809 case reports that were collected from 30.3.2017 to 31.12.2021. RESULTS: There were 5582 cases documenting the use of cannabinoid drugs in psychiatric disorders. More than half of the prescriptions were Dronabinol. 80% of the treatments concerned somatoform disorders. Most of the treatments for other psychiatric disorders also targeted pain. Doctors reported a positive effect on symptoms in at least 75% of the cases. DISCUSSION: Most patients with psychiatric disorders received cannabinoid drugs for pain. The evidence from randomized controlled clinical trials for the use of cannabinoid drugs in psychiatric indications is weak.

Assessing complex PTSD and PTSD: validation of the German version of the International Trauma Interview (ITI).

Background: With the introduction of the ICD-11 into clinical practice, the reliable distinction between Posttraumatic Stress Disorder (PTSD) and Complex Posttraumatic Stress Disorder (CPTSD) becomes paramount. The semi-structured clinician-administered International Trauma Interview (ITI) aims to close this gap in clinical and research settings.Objective: This study investigated the psychometric properties of the German version of the ITI among trauma-exposed clinical samples from Switzerland and Germany.Method: Participants were 143 civilian and 100 military participants, aged M = 40.3 years, of whom 53.5% were male. Indicators of reliability and validity (latent structure, internal reliability, inter-rater agreement, convergent and discriminant validity) were evaluated. Confirmatory factor analysis (CFA) and partial correlation analysis were conducted separately for civilian and military participants.Results: Prevalence of PTSD was 30% (civilian) and 33% (military) and prevalence of CPTSD was 53% (civilians) and 21% (military). Satisfactory internal consistency and inter-rater agreement were found. In the military sample, a parsimonious first-order six-factor model was preferred over a second-order two-factor CFA model of ITI PTSD and Disturbances in Self-Organization (DSO). Model fit was excellent among military participants but no solution was supported among civilian participants. Overall, convergent validity was supported by positive correlations of ITI PTSD and DSO with DSM-5 PTSD. Discriminant validity for PTSD symptoms was confirmed among civilians but low in the military sample.Conclusions: The German ITI has shown potential as a clinician-administered diagnostic tool for assessing ICD-11 PTSD and CPTSD in primary care. However, further exploration of its latent structure and discriminant validity are indicated.

This study validated the German International Trauma Interview (ITI), a semi-structured clinician-administered diagnostic interview for ICD-11 Posttraumatic Stress Disorder and Complex Posttraumatic Stress Disorder.Internal reliability, inter-rater agreement, latent structure, and convergent validity were explored in trauma-exposed clinical and military samples from five different in- and outpatient centres in Germany and German-speaking Switzerland.The findings supported the German ITI's reliability, inter-rater agreement, convergent validity and usefulness from a patient perspective. Future research should explore its factor structure and discriminant validity, for which differences between the samples were found.

Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial).

BACKGROUND: Distressing nightmares are a core symptom of posttraumatic stress disorder (PTSD) and contribute to psychiatric comorbidity, impaired physical health and decreased social functioning. No specific pharmacological treatment for PTSD-related nightmares is yet approved. Preliminary clinical data indicate that cannabinoid agonists can improve nightmares and overall PTSD symptoms in patients with PTSD. The primary objective of the study is to examine the efficacy of oral dronabinol (BX-1) versus placebo in reducing nightmares in patients with PTSD. The secondary objectives of the study are to examine the efficacy of oral BX-1 in reducing other PTSD symptoms. METHODS: The study is designed as a multi-centric, double-blind, randomized (1:1), placebo-controlled, parallel group interventional trial. Eligible patients will be randomized to BX-1 or placebo, receiving a once-daily oral dose before bedtime for 10 weeks. Primary efficacy endpoint is the Clinician-Administered PTSD Scale (CAPS-IV) B2 score for the last week, measuring frequency and intensity of nightmares. Secondary efficacy endpoints are other disorder-specific symptoms in patients with PTSD. Further, tolerability and safety of dronabinol will be assessed. DISCUSSION: This randomized controlled trial will provide evidence whether treating patients with PTSD and nightmares with dronabinol is safe and efficacious. TRIAL REGISTRATION: NCT04448808, EudraCT 2019-002211-25.