Major Depressive Disorder / Psilocybin · Phase 3 Trial

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 3 open-label neuroimaging study registered to investigate psilocybin's effect on rumination and its neural correlates in major depressive disorder. No results are available from this registry record; the study is currently recruiting. The small planned sample and open-label design preclude strong inferences pending outcome data.

What was studied

Phase 3, Interventional, Single Group, Open label, Treatment purpose. Major Depressive Disorder; age from 18 Years; to 55 Years. Intervention: Psilocybin. n = 20. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This study is not yet complete and results are not posted. Clinicians should not draw conclusions about psilocybin efficacy or mechanism in depression from this registry record alone; evidence will depend on completion and publication of results.

Plain-language summary

This is a Phase 3 registry record for an ongoing open-label study with no results posted; the planned design and small sample limit inference to hypothesis-generating potential.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ) (assessed at Baseline, and 3 weeks, 6 weeks, 9 weeks, and 12 weeks after psilocybin administ…); Change in Resting-State Functional Connectivity (assessed at Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psi…); Change in Self-Attribution Task performance (assessed at Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psi…); Change in Task-Based Activity during Self-Attribution Task (assessed at Baseline, day of psilocybin administration, an…

DesignPhase 3, Interventional, Single Group, Open label, Treatment purpose

PopulationMajor Depressive Disorder; age from 18 Years; to 55 Years

Sample size20

InterventionPsilocybin

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment20

PhasePhase 3

Study typeOpen-label

Primary outcome measure 1Change in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ) at Baseline, 3 weeks, 6 weeks, 9 weeks, and 12 weeks after psilocybin administration

Primary outcome measure 2Change in Resting-State Functional Connectivity at Baseline, day of psilocybin administration, 3 weeks, and 12 weeks after psilocybin administration

Primary outcome measure 3Change in Self-Attribution Task performance at Baseline, day of psilocybin administration, 3 weeks, and 12 weeks after psilocybin administration

Primary outcome measure 4Change in Task-Based Activity during Self-Attribution Task at Baseline, day of psilocybin administration, 3 weeks, and 12 weeks after psilocybin administration

Clinical bottom line

Caveats

No results are reported in this registry record; study is actively recruiting.
Open-label design without control group or blinding limits ability to establish efficacy.
Very small planned sample size (20 participants) raises questions about adequacy for Phase 3 designation.
No comparator or standard-of-care arm specified; cannot assess relative effectiveness.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Open-label design without control group limits causal inference.

Directness

moderate

Primary outcomes include both clinical (rumination) and neuroimaging measures in MDD population.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record.

Risk of bias

limited

Open-label design and lack of comparator create risk of performance and detection bias.

Sample adequacy

limited

Estimated enrollment 20 participants is small for Phase 3 claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06247839). This is a study registration, not published results. Lead sponsor: Sharmin Ghaznavi. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Major Depressive Disorder. Interventions: DRUG: Psilocybin. Primary outcome measures: Change in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ) , Baseline, and 3 weeks, 6 weeks, 9 weeks, and 12 weeks after psilocybin administration.; Change in Resting-State Functional Connectivity , Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psilocybin administration.; Change in Self-Attribution Task performance , Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psilocybin administration.; Change in Task-Based Activity during Self-Attribution Task , Baseline, day of psilocybin administration, and 3 weeks, and 12 weeks after psilocybin administration.. Brief summary: This open-label functional Magnetic Resonance Imaging (fMRI) study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with major depressive disorder.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Sharmin GhaznaviNCT06247839Major Depressive DisorderPsilocybin