Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD

To assess the safety and tolerability of psilocybin-assisted therapy in adult participants with PTSD secondary to sexual assault

Incidence and occurrence of treatment emergent adverse events (TEAEs) and SAEs from signing of Informed Consent Form (ICF) until the End of Study (EOS) Visit

To assess the safety and tolerability of psilocybin-assisted therapy in adult participants with PTSD secondary to sexual assault

Incidence of changes in suicidal ideation/behavior (measured using the C-SSRS) score at all visits from Baseline to End of Study Visit

To assess the efficacy of psilocybin-assisted therapy on symptoms of PTSD in adult participants with PTSD secondary to sexual assault

Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to: Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). Scores can range from 0 (absent) - the respondent denied the problem or the respondent's report doesn't fit the DSM-5 symptom criterion" to 4 (extreme/incapacitating) "The respondent described a dramatic symptom, far above threshold.'

To assess the efficacy of psilocybin-assisted therapy on symptoms of PTSD in adult participants with PTSD secondary to sexual assault

Change in the PTSD Checklist (PCL-5) The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Interpretation of the PCL-5 should be made by a clinician. The PCL-5 can be scored in different ways: A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. DSM-5 symptom cluster severity scores can be obtained by summing the scores for the items within a given cluster, i.e., cluster B (items 1-5), cluster C (items 6-7), cluster D (items 8-14), and cluster E (items 15-20). A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20).

To assess the efficacy of psilocybin-assisted therapy on symptoms of PTSD in adult participants with PTSD secondary to sexual assault

Change in State-Trait Anxiety Inventory (STAI) The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983). It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress (e.g., Greene et al., 2017, Ugalde et al., 2014). Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

To assess the efficacy of psilocybin-assisted therapy on symptoms of PTSD in adult participants with PTSD secondary to sexual assault

Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16) total score The Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) is a 16-item self-report questionnaire used to assess the severity of depressive symptoms, with scores ranging from 0 to 27, indicating no to very severe depression.