DeBattista 2006.

Methods	Allocation: randomised. Blindness: participant/personnel, unclear whether blinded at outcome. Duration: 7 days. Assessment points: baseline (day 0), daily during dosing (days 1 to 7), days 14 and 28.
Participants	Diagnosis: psychotic depression. Structured Clinical Interview for DSM Disorders (SCID), DSM IV, clinician interview(s). N = 221. Age: mifepristone group mean ˜ 41 years (SD ˜ 11), placebo group mean ˜ 42 years (SD 11). Sex: 112 M, 109 F. Setting: inpatient and outpatient. History: unclear. Excluded: unstable medication condition, use of systemic or inhaled corticosteroids, ECT in past 3 months, antidepressant and/or antipsychotic in past 7 days, history of illicit drug use in past month, alcohol or drug dependence in past 6 months. Country: USA (29 sites).
Interventions	1. Mifepristone: dose 600 mg/day. N = 105. 2. Placebo: N = 116. Other concurrent treatments: antipsychotics and antidepressants not allowed for 7 days of study, thereafter any indicated treatment.
Outcomes	Global state: rapid response (> 30% reduction BPRS total at days 7 and 28), response (> 30% reduction BPRS total at day 28 but not at day 7), positive psychotic response (< 50% improvement BPRS PSS) and depression response (< 50% improvement HAMD). Leaving the study early. Adverse events: spontaneous report of adverse events.
Notes	Funded by: This work was sponsored by Corcept Therapeutics, Menlo Park, California. “We acknowledge the following disclosures; CD: Speakers Bureau, Wyeth, Cephalon, Pfizer, GSK, Lilly, BMS, Cyberonics. Grant support; Wyeth, GSK, Cephalon, Pritzker Foundation, NARSAD, NIMH, Neuronetics, Cyberonics. Consultant; Corcept Therapeutics, Wyeth, Lilly, Roche, BMS. Stock‐holder; Corcept Therapeutics. JB: CEO and equity‐holder; Corcept Therapeutics, Menlo Park, CA. CB: Statistical consultant; Corcept Therapeutics. LLC: Consultant; GlaxoSmithKline, Novartis, Pfizer, Johnson & Johnson, Sepracor, Cyberonics, Bristol‐Myers Squibb, Medronic, and Wyeth. Grants/Research support; NIH, US Dept of the Interior, Cyberonics, Pfizer, Corcept Therapeutics, Medtronic, and UCB Pharma. Speakers Bureau or has received Honoraria for speaking; Cyberonics, Pfizer, Wyeth, AstraZeneca, and Cephalon."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Patients who met the study criteria were randomised 1:1 to 7 days..." (pg 1344).
Allocation concealment (selection bias)	Unclear risk	Unclear ‐ no statement provided.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "randomised 1:1 to 7 days of inpatient treatment in a double‐blind, placebo controlled, parallel group design" (pg 1344).
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	Missing data imputed using appropriate methods (ITT analysis conducted).
Selective reporting (reporting bias)	Low risk	All outcome measures reported.
Other bias	High risk	Study authors have conflict of interest with sponsor/funding source.