Trial · NCT07479550
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Blinding Success - Correct Identification of Psilocybin at Final Dosing Session | 1 day after the final dosing session (Visit 21, Week 4) | Percentage of participants who correctly guess whether they received a full dose of psilocybin during the final dosing session (Visit 20), assessed using the Blinding Survey at Visit 21. |
| Primary | Blinding Success - Accuracy of Guessed Psilocybin Dose at Final Dosing Session | 1 day after the final dosing session (Visit 21, Week 4) | The dose of psilocybin guessed by participants at Visit 21 compared to the dose actually received at Visit 20, assessed using the Blinding Survey. |
| Secondary | Acute Drug Effects by Dose - Drug Effects Questionnaire (DEQ) | Immediately after emergence at each of the 4 dosing sessions (Visits 5, 10, 15, 20; Weeks 1-4) | Mean differences in acute subjective drug effects between psilocybin doses and placebo, assessed using the Drug Effects Questionnaire (DEQ; Morean et al., 2013) after emergence from anesthesia at each dosing session. The DEQ consists of 5 items rated on visual analog scales; scores are expressed as the mean across items. Minimum score: 0 (no drug effects); Maximum score: 100 (maximum drug effects). Higher scores indicate greater perceived drug effect. |
| Secondary | Mystical-Type Experiences by Dose - Mystical Experiences Questionnaire (MEQ-30) | Immediately after emergence at each of the 4 dosing sessions (Visits 5, 10, 15, 20; Weeks 1-4) | Mean changes in overall and subsection scores of the Mystical Experiences Questionnaire (MEQ-30; Maclean et al., 2012) compared between psilocybin doses and placebo, assessed after emergence from anesthesia at each dosing session. The MEQ-30 consists of 30 items rated on a 0-5 scale across four subscales: Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability. Total scores are calculated by summing all individual items. Minimum score: 0 (no mystical-type experience); Maximum score: 150 (extreme mystical-type experience). Higher scores indicate greater mystical experience intensity. |
| Secondary | Altered States of Consciousness by Dose - Three-Dimensional Altered States of Consciousness Scale (3D-ASCr) | Immediately after emergence at each of the 4 dosing sessions (Visits 5, 10, 15, 20; Weeks 1-4) | Mean changes in overall and dimension scores of the Three-Dimensional Altered States of Consciousness Rating Scale - Revised (3D-ASCr; Stocker et al., 2025) compared between psilocybin doses and placebo, assessed after emergence from anesthesia at each dosing session. The 3D-ASCr consists of 42 items rated on visual analog scales, organized into three higher-order dimensions: Positive Effects (PosE), Distressing Effects (DisE), and Perceptual Effects (PerE). Dimension scores are calculated as means of their constituent subscale means. Minimum score: 0 (no alteration); Maximum score: 100 (maximum alteration). Higher scores indicate greater alteration of consciousness in each dimension; higher PosE scores reflect more positive experiential effects, higher DisE scores reflect more distressing effects, and higher PerE scores reflect greater perceptual effects. |
| Other | Feasibility - Challenging Experiences Questionnaire (CEQ) | Immediately after emergence at Visits 5, 10, 15, and 20 (Weeks 1-4) | Descriptive statistics of challenging experiences by dose of psilocybin versus placebo, assessed using the Challenging Experiences Questionnaire - 7 Item (CEQ-7; Strickland et al., 2024) after emergence from anesthesia at each dosing session. The CEQ-7 consists of 7 items rated on a 6-point scale (0 = none/not at all; 5 = extreme), one item per challenging experience domain (Fear, Grief, Physical Distress, Insanity, Isolation, Death, Paranoia). Total scores are calculated by summing all items. Minimum score: 0; Maximum score: 35. Higher scores indicate greater challenging experience severity. |
| Other | Safety - Incidence and Severity of Adverse Events | Continuously from Visit 1 through Visit 25 (up to 7 weeks) | Incidence, severity, and CTCAE grade of adverse events, including CTCAE Grade 3 or higher cardiopulmonary, neurological, or psychiatric events, coded using MedDRA. Includes abnormal EKG and hemodynamic findings and clinically significant laboratory results. |
| Other | Safety - PACU Discharge Readiness | Within 4 hours of emergence at Visits 5, 10, 15, and 20 (Weeks 1-4) | Incidence of participants meeting post-anesthesia care unit (PACU) discharge readiness criteria within 4 hours of emergence from anesthesia at each dosing session. |
| Other | Safety - Suicidal Ideation and Behavior (C-SSRS) | From Visit 2 through Visit 25 (Screening through Week 7) | Incidence and severity of suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS). Lifetime and Last 10 Years C-SSRS administered at screening (Visit 2); Since Last Visit C-SSRS administered at all subsequent visits. |
| Other | Safety - Positive Urine Drug Screens | Prior to each dosing session at Visits 5, 10, 15, and 20 (Weeks 1-4) | Incidence of positive urine drug screens prior to each dosing session. |
| Other | Pharmacokinetics of Psilocybin | During dosing session | Maximum measured serum concentration (Cmax) of psilocin, the active metabolite of psilocybin |
| Other | Pharmacokinetics of Psilocybin | During dosing sessions | Serum concentration of psilocin at the time of emergence. |
| Other | Clinician-Reported Depressive Symptoms - MADRS | Visits 2, 4, 9, 14, 19, and 25 (Screening through Week 7) | Changes in blinded clinician-reported depression symptoms across placebo, 10mg, and 25mg psilocybin conditions, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery and Asberg, 1979). The MADRS consists of 10 clinician-rated items, each scored from 0 to 6. Total scores are calculated by summing all items. Minimum score: 0 (no depressive symptoms); Maximum score: 60 (severe depression). Higher scores indicate greater depression severity. |
| Other | Participant-Reported Depressive Symptoms - QIDS-SR | Visits 3, 4, 9, 14, 19, 24, and 25 (Baseline through Week 7) | Changes in participant-reported depression symptoms across placebo, 10mg, and 25mg psilocybin conditions, assessed using the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR; Rush et al., 2003). The QIDS-SR consists of 16 items assessing 9 symptom domains; total scores are derived by summing the highest-rated item within each domain. Minimum score: 0 (no depressive symptoms); Maximum score: 27 (severe depression). Higher scores indicate greater depression severity. |
| Other | Anxiety Symptoms - Generalized Anxiety Disorder scale (GAD-7) | Visits 3, 4, 9, 14, 19, 24, and 25 (Baseline through Week 7) | Changes in participant-reported anxiety symptoms across placebo, 10mg, and 25mg psilocybin conditions, assessed using the Generalized Anxiety Disorder scale (GAD-7; Spitzer et al., 2006). ). The GAD-7 consists of 7 self-reported items, each scored from 0 (not at all) to 3 (nearly every day). Total scores are calculated by summing all items. Minimum score: 0 (no anxiety symptoms); Maximum score: 21 (severe anxiety). Higher scores indicate greater anxiety severity. |
| Other | Global Mood - the Positive and Negative Affect Schedule (PANAS) | Daily from Visit 3 through Visit 25 (Baseline through Week 7) | Changes in participant-reported mood across placebo, 10mg, and 25mg psilocybin conditions, assessed daily using the Positive and Negative Affect Schedule (PANAS; Watson et al., 1988). The PANAS consists of 20 items rated on a 5-point scale (1 = very slightly or not at all; 5 = extremely), yielding a Positive Affect subscale (10 items; range 10-50) and a Negative Affect subscale (10 items; range 10-50). Higher Positive Affect scores indicate greater positive mood; higher Negative Affect scores indicate greater negative mood. |
| Other | Global Mood - 12-Point Affect Circumplex (12-PAC) | Daily from Visit 3 through Visit 25 (Baseline through Week 7) | Changes in participant-reported mood across placebo, 10mg, and 25mg psilocybin conditions, assessed daily using a subset of items from the 12-Point Affect Circumplex (12-PAC; Yik et al., 2011). From the 12-PAC, 8 items rated on a 5-point scale (1 = very slightly or not at all; 5 = extremely) are administered to assess low-arousal affect, yielding two mean subscale scores: low-arousal positive affect (4 items; mean range 1-5) and low-arousal negative affect (4 items; mean range 1-5). Higher scores indicate greater endorsement of the respective low-arousal affect dimension. |
| Other | Well-Being - Satisfaction With Life Scale (SWLS) | Visits 3, 9, 14, 19, and 24 (Baseline through Week 6) | Changes in participant-reported life satisfaction across placebo, 10mg, and 25mg psilocybin conditions, assessed using the Satisfaction With Life Scale (SWLS; Diener et al., 1985). The SWLS consists of 5 self-reported items, each scored from 1 (strongly disagree) to 7 (strongly agree). Total scores are calculated by summing all items. Minimum score: 5 (lowest life satisfaction); Maximum score: 35 (highest life satisfaction). Higher scores indicate greater life satisfaction. |
| Other | Well-Being - Scales of Psychological Well-Being (SPWB) | Visits 3, 9, 14, 19, and 24 (Baseline through Week 6) | Changes in participant-reported psychological well-being across placebo, 10mg, and 25mg psilocybin conditions, assessed using the Scales of Psychological Well-Being (SPWB; Ryff and Keyes, 1995). The SPWB 18-item version consists of 18 items rated on a 6-point scale (1 = strongly disagree; 6 = strongly agree), yielding six subscale scores - Autonomy, Environmental Mastery, Personal Growth, Positive Relations with Others, Purpose in Life, and Self-Acceptance - each ranging from 3 to 18, and a total score ranging from 18 to 108. Higher scores indicate greater psychological well-being. |
| Other | Well-Being - Peace of Mind Scale (PoMS) | Visits 3, 9, 14, 19, and 24 (Baseline through Week 6) | Changes in participant-reported peace of mind across placebo, 10mg, and 25mg psilocybin conditions, assessed using the Peace of Mind Scale (PoMS; Lee et al., 2013). The PoMS is a 7-item self-report scale; each item is rated on a 5-point frequency scale from 1 (not at all) to 5 (all the time), with 2 items reverse-scored. The total score is the mean of all items. Minimum score: 1; Maximum score: 5. Higher scores indicate greater peace of mind. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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