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

Phase 2

• Conditions: Anxiety; Depression; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12624000816550
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-02
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Capable of understanding and signing an informed consent form.
2.Aged 18 years and over 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

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 MAOIs, thyroxine or stimulants (amphetamine/methylphenidate). Use of antidepressants or other anxiolytics at stable doses > 4 weeks is acceptable.
6.Participants with severe acute or chronic medical illnesses.
7.Participants with a history of schizophrenia, psychosis, bipolar disorder, borderline personality disorder, and seizure disorders
6.Participants with current active suicidal ideation.
7.Substance abuse disorder, current or within the last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified