A Phase-2, Double-Blind, Randomized, Placebo-controlled, Crossover Dose-Finding, Laboratory-based Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances
Post-traumatic stress disorder (PTSD) affects many people who have experienced traumatic events. A common issue with PTSD is severe sleep disturbances, such as nightmares. Current treatments often do not provide sufficient relief, especially for sleep problems. This study aims to determine whether dexmedetomidine - a medication already used in intensive care - can improve sleep quality in PTSD patients.
• Male or female, aged ≥18 and ≤64 years (inclusive)
• Diagnosis of PTSD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for more than 6 months
• PTSD diagnosis assessed with CAPS-5 (life-time) severity ≥ 2
• Sleep disturbance, e.g., difficulty falling or staying asleep, or restless sleep (Criterion E6 of the DSM-5 criteria for PTSD) is present for at least a month prior to screening and causes clinically significant distress or impairment in social, occupational, or other important areas of functioning
• Sleep disturbance assessed with the PSQI; severity ≥ 5
• Ability (verified by investigator) and willingness to provide informed consent as documented by dated signature