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) |
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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 |
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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 |