Psilocybin-Assisted Psychotherapy for Posttraumatic Stress Disorder in Military Veterans: A Pilot Feasibility Study

Conditions

Posttraumatic stress disorder

Brief summary

Number, percentage and reasons of screen failures and drop-out, Descriptive statistics of the scores on the Treatment Acceptability/Adherence Scale (TAAS-M), measured post-treatment (Visit 16), Qualitative analysis of semi-structured interviews conducted with participants post-treatment (Visit 16), Mean change in CAPS-5-R Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15)., Severity, incidence and frequency of adverse events (AEs), serious adverse events (SAEs), suicidal ideation and behavior, concomitant medication use, and vital signs throughout the study, Descriptive statistics of changes in Columbia Suicide Severity Rating Scale (C-SSRS) scores, Descriptive statistics of concomitant medication use, Mean changes in blood pressure, heart rate, and body temperature from pre-psilocybin administration to end of each Psilocybin Session

Detailed description

Mean change in Sheehan Disability Scale Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15)., Mean change in Beck's Depression Inventory-II Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15)

Related papers

No related papers found yet.

Interventions

DRUGPEX010 Psilocybin Capsules (25 mg Psilocybin)

DRUGPEX010 Psilocybin Capsules (5 mg Psilocybin)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number, percentage and reasons of screen failures and drop-out, Descriptive statistics of the scores on the Treatment Acceptability/Adherence Scale (TAAS-M), measured post-treatment (Visit 16), Qualitative analysis of semi-structured interviews conducted with participants post-treatment (Visit 16), Mean change in CAPS-5-R Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15)., Severity, incidence and frequency of adverse events (AEs), serious adverse events (SAEs), suicidal ideation and behavior, concomitant medication use, and vital signs throughout the study, Descriptive statistics of changes in Columbia Suicide Severity Rating Scale (C-SSRS) scores, Descriptive statistics of concomitant medication use, Mean changes in blood pressure, heart rate, and body temperature from pre-psilocybin administration to end of each Psilocybin Session	—

Measure

Time frame

Number, percentage and reasons of screen failures and drop-out, Descriptive statistics of the scores on the Treatment Acceptability/Adherence Scale (TAAS-M), measured post-treatment (Visit 16), Qualitative analysis of semi-structured interviews conducted with participants post-treatment (Visit 16), Mean change in CAPS-5-R Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15)., Severity, incidence and frequency of adverse events (AEs), serious adverse events (SAEs), suicidal ideation and behavior, concomitant medication use, and vital signs throughout the study, Descriptive statistics of changes in Columbia Suicide Severity Rating Scale (C-SSRS) scores, Descriptive statistics of concomitant medication use, Mean changes in blood pressure, heart rate, and body temperature from pre-psilocybin administration to end of each Psilocybin Session

—

Secondary

Measure	Time frame
Mean change in Sheehan Disability Scale Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15)., Mean change in Beck's Depression Inventory-II Total Severity Score from Baseline (Visit 4) to 13 weeks post Baseline (Visit 15)	—

Outcome results

None listed