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 |
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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. |
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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) |
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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". |