Sanacora 2017.

Study characteristics
Methods	Randomised, parallel‐arm, double‐blind, placebo‐controlled trial
Participants	Diagnosis: DSM‐IV‐TR major depressive disorder N: 302 randomised, 301 went through to the study Age: lanicemine 50 mg group M = 47.7 (SD = 11.19); lanicemine group 100mg M = 47.5 (SD = 11.89); Saline group M = 49.5 (SD = 11.12) Sex: Lanicemine 50mg group 61.4% female; Lanicemine 100 mg group 69.3% female; placebo group 65% female Baseline depression severity: lanicemine 50 mg group MADRS score M = 36.55 (SD = 4.67); lanicemine 100 mg group MADRS score M = 36.02 (SD = 4,74); placebo group MADRS score M = 35.64 (SD = 4.84)
Interventions	Participants completed a washout phase of up to 6 weeks before being randomised to the treatment phase for 12 weeks. Patients were randomly allocated to receive intravenous infusion of lanicemine 50 mg, lanicemine 100 mg, or placebo (saline).
Outcomes	MADRS Response (≥50% reduction from baseline in MADRS total score) Remission (MADRS total score ≤10) CGI‐S CGI‐I QIDS‐SR‐16 Sheehan Disability Scale
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Subjects entering the study drug treatment phase were randomized in balanced blocks equally (1:1:1 ratio), using a unique randomization code generated via Interactive Voice Response System".
Allocation concealment (selection bias)	Low risk	Quote: "Packaging and labeling of study medications could not be used by the investigators or subjects to determine randomization assignment".
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The investigator, patient, and study staff were all blinded."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The investigator, patient, and study staff were all blinded."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Withdrawal rates are distributed almost equally across the treatment groups. Reasons for withdrawal are detailed in figure 1 (page 846).
Selective reporting (reporting bias)	High risk	Trial registration available online (NCT01482221). Post‐treatment follow up phase changed from 8 weeks in protocol to 2 weeks due to difficulties retaining subjects.
Other bias	High risk	Potential bias due to funding by pharmaceutical company. Sponsored by AstraZeneca.