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

Preskorn 2015.

Study characteristics
Methods Double‐blind, randomised, placebo‐controlled trial
Participants Diagnosis: DSM‐IV major depressive disorder without psychotic features
N: 120 randomised, 116 received treatment
Age: GLYX‐13 1mg/kg M = 41.7 (SD = 8.1); GLYX‐13 5 mg/kg M = 44.0 (SD = 11.6); GLYX‐13 10 mg/kg M = 44.2 (SD = 11.5); GLYX‐13 30 mg/kg M = 47.3 (SD = 6.9); placebo M = 44.5 (SD = 12.5)
Sex: GLYX‐13 1mg/kg female 56%; GLYX‐13 5 mg/kg female 60%; GLYX‐13 10 mg/kg female 64.7%; GLYX‐13 30 mg/kg female 47.6%; placebo female 63.6%
Baseline depression severity: GLYX‐13 1 mg/kg HAM‐D17 = 26.10; GLYX‐13 5 mg/kg HAM‐D17 = 25.20; GLYX‐13 10 mg/kg HAM‐D17 = 25.10; GLYX‐13 30 mg/kg HAM‐D17 = 24.60; placebo HAM‐D17 = 26.10
Interventions A single intravenous dose of GLYX‐13 (1 mg, 5, 10 mg, or 30mg/kg) or placebo was administered.
GLYX‐13 1 mg/kg (N = 25)
GLYX‐13 5 mg/kg (N = 20)
GLYX‐13 10 mg/kg (N = 17)
GLYX‐13 30 mg/kg (N = 21)
Placebo (N = 33)
Concomitant treatments: No, 14‐day wash‐out period of anti‐depressant medication completed prior to study entry and no new anti‐depressant drug could be recevied after randomisation.
Outcomes HAM‐D17
Bech‐6
Brief Psychiatric Rating Scale positive symptoms subscale
Columbia Suicide Severity Rating Scale
Response (50% improvement from baseline HAM‐D17 score)
Remission (HAM‐D17 score <10)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Subjects were allocated to treatment groups in a block of 8 randomization sequences generated by a statistician not otherwise associated with the study and assigned sequentially using an interactive webbased randomization assignment system".
Allocation concealment (selection bias) Low risk Quote: "Subjects were allocated to treatment groups in a block of 8 randomization sequences generated by a statistician not otherwise associated with the study and assigned sequentially using an interactive webbased randomization assignment system".
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Stated but not tested.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Stated but not tested.
Incomplete outcome data (attrition bias)
All outcomes Low risk Numbers of withdrawn participants and reasons for withdrawal listed.
Selective reporting (reporting bias) Low risk Protocol available online, outcomes reported in paper.
Other bias High risk Potential for bias due to funding source. Quote: "Funding for this study was provided in its entirety by Naurex, Inc, 1801 Maple Avenue, Suite 4300, Evanston IL 60201, which owns patents, patent applications, and commercialization rights to GLYX‐13".