Post-traumatic stress disorder
Conditions
Brief summary
The primary feasibility endpoint is treatment completion, defined as the proportion of participants who complete all three MDMA-assisted sessions and the assessment within one week after the final integration session., Safety will be assessed by the number of adverse events and serious adverse events, and treatment discontinuations until the end of the study.
Detailed description
Change in CAPS-CA-5 total score from baseline to within one week after the final integration session., NEQ questionnaire at within one week after the final integration session, Change in PROMIS Anxiety, PROMIS Depression, cPTCI, CYRM-R, WAV-12, Cantril ladder, Resilience Cantril ladder, and EQ-5D from baseline to within one week after the final integration session.
Interventions
Sponsors
Stichting Amsterdam UMC
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary feasibility endpoint is treatment completion, defined as the proportion of participants who complete all three MDMA-assisted sessions and the assessment within one week after the final integration session., Safety will be assessed by the number of adverse events and serious adverse events, and treatment discontinuations until the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in CAPS-CA-5 total score from baseline to within one week after the final integration session., NEQ questionnaire at within one week after the final integration session, Change in PROMIS Anxiety, PROMIS Depression, cPTCI, CYRM-R, WAV-12, Cantril ladder, Resilience Cantril ladder, and EQ-5D from baseline to within one week after the final integration session. | — |
Outcome results
None listed