4. Suggested design for future study.
Methods | Allocation: randomised, clearly described. Blinding: double, tested. Duration: 1 week. Need short‐, medium‐ and long‐term follow‐up. |
Participants | Diagnosis: people at ultra‐high risk of developing psychosis. N = 300.* Age: young adults. Sex: male only (due to mifepristone interaction with progesterone receptor). History: demonstrable HPA axis hyperactivity. |
Intervention | 1. Mifepristone: flexible dose 400 to 600 mg/day. N = 150. 2. Placebo. N = 150. |
Outcomes | Global state: relapse, time to transition to psychosis. Service outcomes: admission, time in hospital. Mental state: CGI, Total psychotic (BPRS) and depressive symptoms. General functioning: quality of life measures. Neuroendocrine measurements: cortisol awakening response and circadian rhythm measured on 2 consecutive days. |
Notes | *Powered to be able to identify a difference of ˜ 20% between groups for primary outcome with adequate degree of certainty. |