Berman 2000.
Study characteristics | ||
Methods | Double‐blind randomised controlled cross‐over trial | |
Participants |
Diagnosis: DSM‐IV major depressive episode (1 bipolar disorder, depressed)
N: 9 Age: M = 37 (SD = 10.0) Sex: 56% female Baseline depression severity: ketamine group HRSD = 33.0 (SD = 6.7); placebo group HRSD = 26.9 (SD = 5.8) |
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Interventions | 1 single IV infusion Ketamine (N = 4) 0.5 mg/kg infused over 40 minutes Placebo (N = 3) saline solution infused over 40 minutes Concomitant treatment: no, patients had a 2‐week drug‐free period before commencing treatment |
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Outcomes | HRSD Response rate (≥50% reduction in HRSD scores) BDI VAS BPRS |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details given on randomisation procedure beyond quote: ''four participants were randomly assigned'' |
Allocation concealment (selection bias) | Unclear risk | No details given on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details given on blinding beyond quote: '''in a randomised, double‐blinded manner'' |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details given on blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | High risk | 2/9 participants withdrew to institute antidepressant treatment |
Selective reporting (reporting bias) | High risk | Scores not reported for each measured time point (only baseline and final) and BDI scores missing |
Other bias | Low risk | No other potential sources of bias identified |