A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments with Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

Post-Traumatic Stress Disorder

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (total severity score; primary efficacy outcome measure), PTSD Checklist for DSM-5 (PCL-5), Montgomery-Åsberg Depression Rating Scale (MADRS), Sheehan Disability Scale (SDS), Clinical Global Impression of Improvement (CGI-I), Clinical Global Impression of Severity (CGI-S), Patient Global Impression of Change (PGI-C), Patient Global Impression of Severity (PGI-S), Quick Inventory Depressive Symptoms (QIDS), Pittsburgh Sleep Quality Index (PSQI), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), Post-Traumatic Growth Inventory (PTGI)

Columbia-Suicide Severity Rating Scale (C-SSRS), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI), Adverse events (serious and non-serious) during Methylone treatment, Vital signs (blood pressure [BP], heart rate, temperature) during Methylone treatment, Clinical labs (chemistry, haematology, urinalysis) during Methylone treatment, Electrocardiogram (ECG) during Methylone treatment

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