Investigation to Understand and Optimize... — Clinical Trial Details

Participants receive a single 25 mg oral dose of psilocybin within a "set and setting" framework including preparatory sessions, two facilitators during dosing and post-dose integration sessions.

After dosing, subjects are randomised to taVNS, sham taVNS, or no taVNS to evaluate effects on depressive symptoms, anxiety, well-being, functional outcomes, social behaviour and safety.

Outcomes include clinical rating scales, measures of real-world social behaviour and early behavioural responses associated with longer-term treatment outcomes.

Inclusion Criteria:
Current diagnosis of Major Depressive Disorder (MDD) with a depressive episode lasting ≥ 60 consecutive days at screening, confirmed by structured clinical interview.
Medically healthy as determined by the screening physician, with no significant medical conditions that would interfere with participation or safety.
Ages 18–70 years; able to provide informed consent.

Exclusion Criteria:
History or presence of any psychiatric or medical condition that could pose a safety risk, interfere with participation, or confound study results (e.g., bipolar disorder, psychosis, seizure disorder, or cardiovascular disease).
Known family history of a psychotic disorder (e.g., schizophrenia or schizoaffective disorder) in a first-degree relative.
Current active suicidal ideation with a specific plan within the prior 2 weeks as assessed by clinical interview and validated instrument (e.g., C-SSRS).
Suicide attempt within the prior 6 months.
Current diagnosis of a substance use disorder.
Abnormal ECG at screening that may increase risk (e.g., prolonged QTc, arrhythmias) as determined by the study physician.
Unwilling or unable to discontinue prescription psychotropic medications for the duration of study participation, including required washout periods.
Any condition, finding, or behaviour (including suspected deception or noncompliance) that renders the participant unsuitable or likely to interfere with data integrity or safety.

Company

Product

Legal

Investigation to Understand and Optimize Psilocybin (OPTIMIZE)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin + taVNS

Interventions

Psilocybin + Sham taVNS

Interventions

Psilocybin only

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details