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. 2016 Jan 4;2016(1):CD006995. doi: 10.1002/14651858.CD006995.pub2

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.