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

Lapidus 2014.

Study characteristics
Methods Double‐blind randomised controlled cross‐over trial
Participants Diagnosis: DSM‐IV major depressive disorder; IDS‐C score ≥ 30
N: 20
Age: M = 48.0 (SD = 12.8)
Sex: 50% female
Baseline depression severity: IDS‐C = 42.7 (SD = 8.5)
Interventions 1 single intranasal infusion
Ketamine (N = 10) 50 mg
Placebo (N = 10)
Study drug or placebo provided in identical syringes containing clear solutions of either 100 mg/mL ketamine in.9% saline or saline alone. 5 intranasal applications of solution separated by 5 minutes
Concomitant treatment: Yes, patients continued on existing psychotropic medications
Outcomes MADRS
Response rate (≥ 50% reduction in MADRS scores)
QIDS‐SR
HAMA
BPRS
CADSS
YMRS
SAFTEE
Adverse events
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: ''The order of treatment periods was randomly assigned by the research pharmacy using permuted blocks of size four''
Allocation concealment (selection bias) Low risk Quote: ''The order of treatment periods was randomly assigned by the research pharmacy using permuted blocks of size four''
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: ''All study investigators, anesthesiologists, and raters were blind to treatment assignment. Study drug or placebo was provided in identical syringes, containing clear solutions of either 100 mg/mL ketamine in.9% saline or saline alone''
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: ''Raters were blind to treatment assignment''
Incomplete outcome data (attrition bias)
All outcomes Low risk Study reports dropouts
Selective reporting (reporting bias) Unclear risk Protocol unavailable. Data reported matches methods
Other bias Low risk No other potential sources of bias identified