ACTRN12623000618651
Recruiting
Phase 1
Exploratory trial to assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP) involving family-members compared to standard PAP, in adults with treatment-resistant major depressive disorder. (TRMDD).
Reset Mind Science0 sites60 target enrollmentJune 6, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment-resistant major depressive disorder (TRMDD).
- Sponsor
- Reset Mind Science
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant must be over 18 years of age inclusive, up to 65 years old at
- •the time of signing the informed consent.
- •Participant is able to read, understand and agree with the procedures of
- •Participants must be diagnosed with major depressive disorder and have
- •moderate to severe depression (17\+ on the 17\-item Hamilton Depression
- •Rating scale \[HAM\-D17]).
- •Participants have failed to respond to two adequate courses of
- •antidepressant treatment of different pharmacological classes lasting at least
- •6 weeks within the current depressive episode and have not been subject to
- •Electroconvulsive therapy (ECT) within 6 months prior to the study.
Exclusion Criteria
- •Participants unable to provide written informed consent.
- •Participants with history of current or previously diagnosed psychotic
- •disorder, or bipolar disorder.
- •Immediate family member with a diagnosed psychotic disorder.
- •Participants that are pregnant or breastfeeding. Positive pregnancy test
- •at screening or prior to any psilocybin administration or refusal to have an
- •on\-site B\-HCG pregnancy test prior to any psilocybin administration.
- •Participants who may have sexual contact, without contraceptive
- •measures, with a person who may become pregnant during or within 90 days
- •(or 3 months) of cessation of the psilocybin IMP.
Outcomes
Primary Outcomes
Not specified
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