Clinical TrialDepressive DisordersPsilocybinNot yet recruiting

Feasibility Study of the Effect of Psilocybin in Response to Brief Psychological Input with Psychological Flexibility as a Mediating Factor on adults with Mild to Moderate Depression or Anxiety.

This open-label Phase II trial (n=30) evaluated the safety and efficacy of psilocybin for anxiety depression.

Target Enrollment
30 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

It has been shown that different psychological factors may influence a person’s response to treatment. For example, studies have shown that people with certain character traits, beliefs, thought processes etc may be more likely to respond to certain therapy or treatment more than others. Psilocybin has been shown to result in temporary changes in these mental processes that may create a change in the way a person receives and processes new information – such as psychological therapy. In this study, all participants will receive psilocybin within two to four weeks after completion of therapy, and then changes in mood and cognition will be followed-up.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Psilocybin

Participants

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
    Randomized
  • Target Enrollment30 participants
  • Timeline
    Start: 2025-05-01
    End: 2025-11-01
  • Compound
  • Topic

Locations

Unknown facilityAustralia

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