Treating Nightmares in Posttraumatic Stress Disorder with the α-adrenergic Agents Clonidine and Doxazosin: A Randomized-Controlled Feasibility Study - ClonDoTrial

Posttraumatic Stress Disorder

Primary efficacy endpoint: 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 (10 weeks, visit 9). A lower score indicates less frequent and/or intense 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, at Visit 2 – Visit 8, Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week) at Visit 7 and Visit 9, Change from baseline of the Pittsburgh Sleep Quality Index- Addendum for PTSD (PSQI A) (PTSD related sleep symptoms) at Visit 7 and Visit 9, Change from baseline of the Montgomery Asberg Depression Inventory (MADRS) at Visit 7 and Visit 9, Weekly mean of change from baseline of the patients daily total sleep time (in minutes), sleep onset latency at night (in minutes), recuperation of night sleep (5-point Likert scale, 1 = very much; 5 = not at all), and time awake at night (in minutes), number of nightmares last night (0, 1, 3, 4 or more) and intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries during Visit 2 – Visit 9, Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5) at Visit 7 and Visit 9, Change from baseline of the Borderline Symptom List 23 (BSL-23) score at Visit 7 and Visit 9, Change from baseline of the Health-Related Quality of Life (EQ-5D) score at Visit 7 and Visit 9, Overall patient status measured by the Patient Global Impression of Change (PGIC) at Visit 7 and Visit 9, Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS) at Visit 7 and Visit 9, Change from baseline of the Pittsburgh Sleep Quality Index (PSQI) at Visit 7 and Visit 9, Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ) at Visit 7 and Visit 9, 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 (Visit 9), Remitter analysis: proportion of patients showing full remission of nightmares defined as CAPS-IV B2 = 0, assessed at the end of treatment (Visit 9)

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