The Acute and Long-term Impact of Support in Psilocybin Therapy for Depression: The Psilocybin Setting Trial (PSISET)

Conditions

Depression

Brief summary

Between group differences (psychotherapy vs basic support) in MADRS score change from baseline to Week 10, Between group differences (psychotherapy vs SoC) in MADRS score change from baseline to Week 10

Detailed description

Between group differences (psychotherapy vs basic support and psychotherapy vs SoC)) in proportion of participants achieving ≥50% re duction in MADRS and remission (MADRS ≤10) at Week 10, 26, and 52, Between group differences in changes in MADRS-S, MDI, GAD-7, PHQ, WHOQOL-BREF, SWLS, MPFI, ECR-SF, TEQ and PSQI from base line to follow-ups, Correlation between measures of psychothera peutic mechanisms (WAI-SR, PBAT, qualitative interviews), and changes in treatment out comes, Correlation between measures of the psyche delic experience (MEQ30, 5D-ASC, EBI, CEQ, PMQ-SF, SDI-A, PEQ, qualitative interviews) and changes in treatments outcomes, Correlation between blood biomarkers (e.g., BDNF, inflammatory markers) and changes in treatment outcomes, Assessment of psychotic symptoms, suicidality, worsening of depressive symptoms and adverse events at follow-ups

Related papers

No related papers found yet.

Interventions

DRUGPEX010 Psilocybin Capsules ( 25mg psilocybin)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Between group differences (psychotherapy vs basic support) in MADRS score change from baseline to Week 10, Between group differences (psychotherapy vs SoC) in MADRS score change from baseline to Week 10	—

Secondary

Measure	Time frame
Between group differences (psychotherapy vs basic support and psychotherapy vs SoC)) in proportion of participants achieving ≥50% re duction in MADRS and remission (MADRS ≤10) at Week 10, 26, and 52, Between group differences in changes in MADRS-S, MDI, GAD-7, PHQ, WHOQOL-BREF, SWLS, MPFI, ECR-SF, TEQ and PSQI from base line to follow-ups, Correlation between measures of psychothera peutic mechanisms (WAI-SR, PBAT, qualitative interviews), and changes in treatment out comes, Correlation between measures of the psyche delic experience (MEQ30, 5D-ASC, EBI, CEQ, PMQ-SF, SDI-A, PEQ, qualitative interviews) and changes in treatments outcomes, Correlation between blood biomarkers (e.g., BDNF, inflammatory markers) and changes in treatment outcomes, Assessment of psychotic symptoms, suicidality, worsening of depressive symptoms and adverse events at follow-ups	—

Measure

Time frame

Between group differences (psychotherapy vs basic support and psychotherapy vs SoC)) in proportion of participants achieving ≥50% re duction in MADRS and remission (MADRS ≤10) at Week 10, 26, and 52, Between group differences in changes in MADRS-S, MDI, GAD-7, PHQ, WHOQOL-BREF, SWLS, MPFI, ECR-SF, TEQ and PSQI from base line to follow-ups, Correlation between measures of psychothera peutic mechanisms (WAI-SR, PBAT, qualitative interviews), and changes in treatment out comes, Correlation between measures of the psyche delic experience (MEQ30, 5D-ASC, EBI, CEQ, PMQ-SF, SDI-A, PEQ, qualitative interviews) and changes in treatments outcomes, Correlation between blood biomarkers (e.g., BDNF, inflammatory markers) and changes in treatment outcomes, Assessment of psychotic symptoms, suicidality, worsening of depressive symptoms and adverse events at follow-ups

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Outcome results

None listed