Arabzadeh 2018.
| Study characteristics | ||
| Methods | Randomised, placebo‐controlled, double‐blind, controlled trial | |
| Participants |
Diagnosis: DSM‐5 major depressive disorder
N: 90 randomised, 81 completed the study Age: ketamine 50 mg/day group M = 34.31 (SD = 6.73); placebo group M = 33.72 (SD = 8.34) Sex: ketamine 50 mg/day group 36.6% female; placebo group 40.0% female Baseline depression severity: ketamine 50 mg/day group HDRS score M = 24.17 (SD = 2.31); placebo group HDRS score M = 24.62 (SD = 3.52) |
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| Interventions | All patients received setraline (150 mg a day). As an adjuvant, they recieved either 50 mg/day ketamine or placebo. Patients were followed for 6 weeks. Ketamine 50 mg/day group (N = 41) ‐ prescribed as 25 mg twice daily. Placebo group (N = 40) Concomitant treatment: No, patients were excluded from the study if they had received antidepressant drugs within the previous month. |
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| Outcomes | HDRS Side effects Response rates (≥ 50% reduction in HDRS score at the termination of the trial) Remission rates (HDRS scors ≤ 7 at the termination of the trial). |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization of patients to either ketamine or placebo groups was done by a computerized random number generator (allocation ratio 1/1)." |
| Allocation concealment (selection bias) | Low risk | Quote: "Allocation was concealed using successively numbered, opaque, and sealed envelopes". |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "The patients, the physician, and the statistician were all blind to allocation. The placebo and ketamine capsules were identical in shape, size, color, texture, and odor." No further details given. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The patients, the physician, and the statistician were all blind to allocation. The placebo and ketamine capsules were identical in shape, size, color, texture, and odor." No further details given. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Exclusion and withdrawal rates at each time point are recorded |
| Selective reporting (reporting bias) | Unclear risk | Protocol unavailable |
| Other bias | Low risk | No other potential sources of bias identified |