Quiroz 2016.
Study characteristics | ||
Methods | Double‐blind, randomised, placebo‐controlled, multi‐centre trial | |
Participants |
Diagnosis: DSM‐IV‐TR major depressive disorder N: 333 Age: basimglurant 0.5 mg group M = 45.8 (SD = 10.8); basimglurant 1.5 mg group M = 47.0 (SD = 17.1); placebo group M = 47.1 (SD = 11.3) Sex: basimglurant 0.5bmg group 62.5% female; basimglurant 1.5bmg group 69.4% female; placebo group 63.3% female Baseline depression severity: basimglurant 0.5bmg group MADRS = 31.1 (SD = 3.9); basimglurant 1.5bmg group MADRS = 31.3 (SD = 4.6); placebo group MADRS = 31.1 (SD = 4.7) |
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Interventions | Patients were randomised to receive 6‐weeks of treatment with 0.5 mg basimglurant, 1.5 mg basimglurant, or placebo, orally once daily. This was adjunctive to their ongoing antidepressant medication therapy. | |
Outcomes | MADRS QIDS‐SR16 CGI‐S SDS (items 2‐3) Q‐LES‐Q‐SF PGI‐I Response (≥50% reduction in MADRS total score from baseline) Remission (MADRS total score ≤10) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients randomised in a 1:1:1 ratio. |
Allocation concealment (selection bias) | Low risk | Patients randomised in a 1:1:1 ratio. |
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 | Diagram of patient numbers and reasons for withdrawal included in figure 1 (page 678). |
Selective reporting (reporting bias) | Low risk | Trial registration available online (NCT01437657). All outcomes reported. |
Other bias | High risk | Potential funding bias. Quote: "This study was sponsored by F. Hoffmann‐La Roche Ltd." |