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

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)
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)
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."