Clinical TrialAnxiety DisordersPsilocybinNot yet recruiting

Feasibility study testing the protocol of single dose of psilocybin given to people who have had little improvements with brief psychological intervention

This open-label trial (n=30) will study the feasibility of administering a single dose of psilocybin (25mg) to adults with mild to moderate depression or anxiety who have shown limited improvement with brief psychological intervention.

Target Enrollment
30 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, non-randomised, single-group feasibility study (n=30) administering a single morning oral dose of psilocybin 25 mg with 8 hours monitoring to adults with moderate depression or anxiety who had limited benefit from brief psychological interventions.

Screening includes one two-hour session; acute measures at ~4 hours, subacute at 24 hours, and outcomes at 6 and 12 weeks. Primary outcomes include recruitment and retention at dosing and follow-up and composite depression/anxiety scores (DASS-21, BAI, BDI-2).

Study Protocol

Preparation

1 sessions
120 min each

Dosing

1 sessions
480 min each

Integration

sessions

Therapeutic Protocol

act

Study Arms & Interventions

Psilocybin 25 mg

experimental

Single-group open-label administration of oral psilocybin 25 mg with psychological support and monitoring.

Interventions

  • Psilocybin25 mg
    via Oral• single dose

    Morning administration with 8-hour monitoring; review of prior brief therapy content (ACT components) during session.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 1. Capable of understanding and signing an informed consent form.
  • 2. Aged 25 - 60 years on the day of consent.
  • 3. Psychiatric history: Clinical interviews and assessments by referral agent - psychologists at student health/community mental health teams/private clinics.
  • 4. Participants with anxiety: Baseline scores of moderate to severe anxiety according to DASS-21 criteria and clinical assessment from referral agent (psychologist).
  • 5. Participants with depression: Baseline scores of moderate to severe depression according to DASS-21 criteria and clinical assessment from referral agent (psychologist).

Exclusion Criteria

  • To be included in the study, participants must meet none of the following exclusion criteria:
  • 1. Female participants who are or intend to become pregnant, or are lactating.
  • 2. Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved).
  • 3. Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
  • 4. Participants with cardiovascular conditions.
  • 5. Current use of antidepressants, anxiolytics, MAOIs, thyroxine or stimulants (amphetamine/methylphenidate).
  • 6. Participants with severe, acute or chronic medical illnesses.
  • 7. Participants with a history of schizophrenia, psychosis, bipolar disorder, borderline personality disorder, or seizure disorders.
  • 8. Participants with a family history of schizophrenia, psychosis, or bipolar disorder.
  • 9. Participants with current active suicidal ideation.
  • 10. Substance abuse disorder, current or within the last 6 months.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment30 participants
  • Timeline
    Start: 2025-02-01
    End: 2026-03-31
  • Compound
    Psilocybin
  • Topic
    Anxiety Disorders

Locations

Unknown facility — Australia

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