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. 2021 Sep 12;2021(9):CD011612. doi: 10.1002/14651858.CD011612.pub3

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)
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.
Outcomes MADRS
Response rates (≥50% reduction from the baseline MADRS)
Remitter rates (MADRS total score ≤10)
QIDS‐SR
BPRS
YMRS
CADSS
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.