Psilocybin for Amblyopia - Targeting Critical Periods in Humans
NCT07920081, Phase 1, Phase 2, Recruiting, Johns Hopkins University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Psilocybin for Amblyopia - Targeting Critical Periods in Humans | ClinicalTrials.gov |
| NCT number | NCT07920081 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 24 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Johns Hopkins University | ClinicalTrials.gov |
| Conditions | Amblyopia | ClinicalTrials.gov |
| Interventions | Amblyopia Therapy, 1 mg Psilocybin, 5 mg Psilocybin, 10 mg Psilocybin, 15 mg Psilocybin, 20 mg Psilocybin, 25 mg Psilocybin | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Amblyopic Eye Visual Acuity | from Baseline to two weeks after experimental drug session 2 | Measured using LogMAR scale | ClinicalTrials.gov |
| Primary | Change in Fellow Eye Visual Acuity | from Baseline to two weeks after experimental drug session 2 | Measured using LogMAR scale | ClinicalTrials.gov |
| Secondary | Challenging Experiences Questionnaire (CEQ) | Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart). | The Challenging Experience Questionnaire (CEQ) is a self-report measure designed to assess the intensity and quality of difficult or distressing experiences during psychedelic states. Score range 0-5, 0 is equivalent to no challenging experiences and 5 is an extreme (more than ever before in my life). Higher score "more difficult." | ClinicalTrials.gov |
| Secondary | 11-Dimensional Altered States of Consciousness Questionnaire (11D-ASC) | Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart). | The 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods. The 11 dimensions are: 1) Experience of Unity, (2) Spiritual Experience, (3) Blissful State, (4) Insightfulness, (5) Disembodiment, (6) Impaired Control and Cognition, (7) Anxiety, (8) Complex Imagery, (9) Elementary Imagery, (10) Audio-Visual Synesthesia, and (11) Changed Meaning of Percepts. Each item is rated on a visual analog scale from 0 to 100, and scores for each dimension are calculated as the mean of the corresponding items, ranging from 0 to 100. Higher scores indicate greater intensity of the respective subjective experience, rather than a uniformly better or worse outcome. | ClinicalTrials.gov |
| Secondary | The World Health Organization-Five Well-Being Index (WHO-5) | At the preparation session, one and two weeks after the first experimental drug administration session, and one, two, and eight weeks after the second drug administration session. | The WHO-5 is a five-item self-report measure of mental well-being over the preceding two weeks. Each item is scored from 0 to 5, yielding a raw total score ranging from 0 to 25. The raw score can be multiplied by four to obtain a percentage score ranging from 0 to 100. Higher scores indicate better mental well-being. | ClinicalTrials.gov |
| Secondary | Amblyopia and Strabismus Questionnaire: English (ASQE) | At the preparation session, two weeks after the first experimental drug administration session, and two and eight weeks after the second experimental drug administration session | The ASQE is a 26-item self-report questionnaire assessing vision-related quality of life in adults with amblyopia and strabismus. Item responses are converted to scores ranging from 0 to 100, and the total score is calculated as the mean of the item scores, ranging from 0 to 100. Higher scores indicate better vision-related quality of life, with 0 representing the worst and 100 the best possible outcome. | ClinicalTrials.gov |
| Secondary | Sheehan Disability Scale (SDS) | At the preparation session, two weeks after the first drug administration session, and two and eight weeks after the second drug administration session. | The Sheehan Disability Scale (SDS) is a patient-rated questionnaire assessing functional impairment across three domains: work/school, social life, and family life/home responsibilities. Each domain is rated on an 11-point scale from 0 (no impairment) to 10 (extreme impairment). The three domain scores are summed to yield a total score ranging from 0 to 30. Higher scores indicate greater functional impairment (worse functioning), while lower scores indicate less impairment (better functioning). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)