Carspecken 2018.
Study characteristics | ||
Methods | Double‐blinded randomised clinical trial | |
Participants | Veterans scheduled for an index course of ECT for treatment of a major depressive episode associated with treatment resistant major depressive disorder Diagnosis: DSM‐V major depressive disorder N: 52 Age:kKetamine group M = 50 (SD = 12); methohexital M = 47 (SD 12) Sex: ketamine 26% female; Methohexital 11% female Baseline depression severity: ketamine group PHQ‐9 M = 21.1 (SD = 3.9); Methohexital group PHQ‐9 M = 21.5 (SD = 3.6) |
|
Interventions | Intravenous racemic ketamine (1‐2 mg/kg) or methohexital (1‐2 mg/kg), in addition to ketorolac 30 mg for induction of general anesthesia. Participants in the ketamine arm received 1 mg to 2 mg of IV midazolam to mitigate post‐procedural psychedelic effects. Concomitant treatment: yes. Quote: "Outpatient benzodiazepines were discontinued 48 hours before ECT, whereas all other psychiatric medications were continued during the study." |
|
Outcomes | HAM‐D PHQ‐9 MOCA |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “"Patient randomization was performed using permuted block randomization to ensure number of subjects assigned to each treatment arm was balanced" |
Allocation concealment (selection bias) | Low risk | Quote: “"Patient randomization was performed using permuted block randomization to ensure number of subjects assigned to each treatment arm was balanced" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: “"Subjects and depression score raters were blinded to study drug intervention. Because of feasibility issues, anesthesiologists and psychiatrists were not blinded during ECT sessions." Effectiveness of blinding not assessed. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Effectiveness of blinding not assessed. Unclear if cognitive measured were blinded as they were completed by psychiatrists who were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study CONSORT flow chart included. |
Selective reporting (reporting bias) | Low risk | Study protocol available, outcomes reported as expected. |
Other bias | Low risk | None identified. |