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NCT04123314 · ClinicalTrials.gov registry record · Early Phase 1
Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease
A Early Phase 1 study of Depression and Alzheimer Disease, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04123314: Recruiting Early Phase 1 study of Depression and Alzheimer Disease, sponsored by Johns Hopkins University.
NCT04123314 is a Early Phase 1 study of Depression and Alzheimer Disease that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 20 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04123314, a Early Phase 1 study of Depression and Alzheimer Disease, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This open-label pilot study examines whether the hallucinogenic drug, psilocybin, given under supportive conditions, is safe and effective for depression in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD). This study will also assess whether psilocybin may improve quality of life in those individuals.
Primary Outcome
The Cornell Scale for Depression in Dementia (CSDD) is administered via patient and informant interviews to assess the presence and severity of depressive mood and behavioral symptoms during the past week. Has 19 items, each scored from 0 to 2 with higher scores indicating severe symptom.Total score range from 0 to 38.
Conditions Studied
Interventions
- DRUG Psilocybin
Study Locations (1)
Maryland
- Johns Hopkins Center for Psychedelic and Consciousness Research - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-03-24 |
| Est. Completion | 2026-12-31 |
| Phase | Early Phase 1 |
What NCT04123314 shows while recruiting
NCT04123314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin is the first listed.
NCT04123314 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04123314 about?
NCT04123314 is a clinical study titled "Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease". This open-label pilot study examines whether the hallucinogenic drug, psilocybin, given under supportive conditions, is safe and effective for depression in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD). This study will also assess whether psilocybin may improve quali...
What is the current status of trial NCT04123314?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2021-03-24. Estimated completion is 2026-12-31.
What conditions does trial NCT04123314 study?
This clinical trial studies the following conditions: Depression, Alzheimer Disease, Mild Cognitive Impairment, Depressive Symptoms.
What interventions are being tested in trial NCT04123314?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT04123314?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04123314 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04123314's enrollment target sits among peer trials
20 612th of 679 higher than 58 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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