Sanacora 2014 (b).
| Study characteristics | ||
| Methods | Double‐blind randomised controlled trial | |
| Participants |
Diagnosis: DSM‐IV major depressive disorder; history of poor response (defined as treatment failure on two or more antidepressants after exposure at adequate doses or maximum tolerated doses for ≥ 4 weeks); HRSD‐17 score ≥ 26; CGI‐S score ≥ 5; QIDS‐SR score ≥ 21. However, to improve recruitment criteria reduced to HRSD‐17 score ≥ 20; CGI‐S score ≥ 4; QIDS‐SR score ≥ 16 N: 152 Age: lanicemine 100 mg group M = 45.9 (SD = 10.0); lanicemine 150 mg group M = 46.6 (SD = 9.4); placebo group M = 44.4 (SD = 10.1) Sex: lanicemine 100 mg group 71% female; lanicemine 150 mg group 61% female; placebo group 61% female Baseline depression severity: lanicemine 100 mg group MADRS = 33.3 (SD = 5.6); lanicemine 150 mg group MADRS = 34.1 (SD= 5.0); placebo group MADRS = 33.5 (SD = 4.5) |
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| Interventions | 3 weeks treatment Lanicemine (AZD6765) (N = 51) 100 mg, 3 IV infusions per week Lanicemine (AZD6765) (N = 51) 150 mg, 3 IV infusions per week Placebo (N = 50) 150 mg, 3 IV infusions per week Concomitant treatment: Yes, treatment adjunct to ongoing psychotropics that included at least one antidepressant |
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| Outcomes | MADRS Response rate (≥ 50% reduction in MADRS scores) Remission rate (MADRS score ≤ 10) HAMA HRSD QIDS‐SR CGI‐S CGI‐I Q‐LES‐Q CADSS Adverse events |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: ''patients were randomised in a 1:1:1 ratio'' no further details given |
| Allocation concealment (selection bias) | Unclear risk | No details given on allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: ''double‐blind'' no further details given |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: ''double‐blind'' no further details given |
| 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 |