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). |