Hu 2016.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group trial | |
Participants |
Diagnosis: DSM‐IV major depressive disorder
N: 30 randomised (27 completed the trial) Age: escitalopram and placebo group M = 41.0 (SD = 11.1); escitalopram andIV ketamine group M = 36.7 (SD = 14.0) Sex: escitalopram and placebo group 71.4% female; escitalopram and IV ketamine group 53.8% female Baseline depression severity: escitalopram and placebo group MADRS score M = 32.3 (SD = 6.5); escitalopram and IV ketamine group MADRS score M = 36.5 (SD = 7.8) |
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Interventions | Patients meeting entry criteria entered a 2‐week wash‐out phase of previously taken psychtropic medications (fluoxetine = 4 weeks). Patients were then randomised to 4 weeks of fixed‐dose escitalopram10 mg/day plus a single saline solution infusion (placebo) or fixed dose escitalopram 10 mg/day plus a single sub‐anaesthetic dose of i.v. ketamine hydrochloride administered over 40minutes. Escitalopram and placebo group (N = 14) Escitalopram andIV ketamine group (N = 13) Concomitant treatments: yes, other medications not affecting the central nervous system were allowed. |
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Outcomes | MADRS Response rates (≥50% reduction from the baseline MADRS) Remitter rates (MADRS total score ≤10) QIDS‐SR BPRS YMRS CADSS |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No further information beyond, "patients were randomized according to a table of random numbers". |
Allocation concealment (selection bias) | Unclear risk | No information given on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information given beyond, "The anesthesiologist was blind to the group membership of patients". No direct information regarding blinding of participants. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Two raters with >5 years of clinical experience and blind to the study protocol and treatment assignments indepently assessed patients" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study reports dropouts. Dropout last assessment carried forward. |
Selective reporting (reporting bias) | Unclear risk | Protocol unavailable |
Other bias | Low risk | Funded by University. No conflict of interests. |