Downey 2016.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐groups trial | |
Participants |
Diagnosis: DSM‐IV major depressive episode
N: 60 (randomised) Age: lanicemine M = 26.7; ketamine M = 27.1; Placebo M = 25.7 Sex: lanicemine group 60% female; ketamine 61.9% female; Placebo group 57.9% female Baseline depression severity: lanicemine group BDI score M = 34.5 (SD = 9.3); Ketamine group BDI score M = 30.94 (SD = 7.1); Placebo group BDI score M = 25.72 (SD = 7.67) |
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Interventions | Participants received a constant intravenous infusion of lanicemine (100 mg total dose), ketamine (0.5 mg/kg total dose) or placebo (0.9% saline) each made up to 40 mL volume and infused for 60 minutes. Concomitant treatment: quote: "Participants were drug‐free but not drug naive" |
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Outcomes | BDI MADRS CADSS BOLD phMRI signal in the sgACC |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "participants were randomized". No further details given on randomisation procedure. |
Allocation concealment (selection bias) | Low risk | Quote: "The research pharmacies at each site held separate randomization codes and dispensed the infusions on the day of the experiment labelled with a code number". |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "The research pharmacies at each site held separate randomization codes and dispensed the infusions on the day of the experiment labelled with a code number". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study reports dropouts (zero). |
Selective reporting (reporting bias) | Unclear risk | No information given. |
Other bias | High risk | Potential bias due to funding by pharmaceutical company. Quote: "This study was wholly sponsored by AstraZeneca". |