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

Belanoff 2001.

Methods Allocation: randomised.
 Blindness: participant/personnel, unclear whether blinded at outcome.
 Duration: 4 days.
Design: cross‐over (× 1).
Participants Diagnosis: major depression with psychotic features. DSM IV, clinician interview(s).
 N = 5.
 Age: range 44 to 67 years; average mifepristone ˜ 48 (SD 4), placebo 56 (SD ˜ 12) years (first arm)
 Sex: 3 M, 2 F (first arm).
 Setting: inpatient.
 History: duration of illness ‐ mifepristone 4.5 months (SD ˜ 5), placebo 98 months (SD 123)
 Excluded: any sign of Cushing syndrome apart from hypercortisolaemia, women of child‐bearing potential, patients using illicit drugs within a month before admission, patients consuming up to 2 ounces of alcohol daily.
Country: USA.
Interventions 1. Mifepristone: dose 600 mg/day. N = 2.
2. Placebo: N = 3.
Other concurrent treatments: no antipsychotic medication for 3 days before entering study, no antidepressant upon entering study, no participants started on antidepressant medication while in study, benzodiazepines permitted for insomnia and acetaminophen for headaches.
Outcomes Mental state: total psychotic symptoms (BPRS), depression (HAMD total score).
Global state: leaving the study early.
Adverse event: overall adverse event rate.
Unable to use: cognition paragraph recall (not reported).
Notes All means and SDs were calculated from individual data by BG.
Funded by NARSAD Young Investigator Award, Pritzker Foundation, NIMH.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "Randomised"; no other statement provided. Imbalance in duration of illness between groups calls into question the success of randomisation.
Allocation concealment (selection bias) Unclear risk Unclear ‐ no statement provided.
Blinding (performance bias and detection bias) 
 All outcomes Low risk "..patients served as their own controls in a random‐assignment, double‐blind crossover design" (pg 517).
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "double‐blind" ‐ probably undertaken.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "double‐blind" ‐ probably undertaken.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data.
Selective reporting (reporting bias) High risk Two outcome measures not reported in the results: Clinical Global Impression (CGI) scale, paragraph recall cognitive test.
Other bias High risk Small sample size (n = 5).