Skip to main content
. 2021 Sep 12;2021(9):CD011612. doi: 10.1002/14651858.CD011612.pub3

Salardini 2016.

Study characteristics
Methods Randomised, double‐blind, placebo‐controlled, parallel‐group trial
Participants Diagnosis: DSM‐IV‐TR major depressive disorder
N: 64
Age: riluzole group M = 34.56 (SD = 7.23); placebo group M = 33.23 (SD = 7.25)
Sex: riluzole group 26.7% female; placebo group 36.7% female
Baseline depression severity: riluzole group HDRS score M = 24.43 (SD = 2.14); placebo group HDRS score M = 23.63 (SD = 3.61)
Interventions Participants were randomised to receive either 50 mg riluzole bi‐daily or placebo for six weeks. All patients received 20 mg/day citalopram for the first week and 40 mg/day for the subsequent 5 weeks.
Participants were not allowed to undergo any behavioral intervention therapy or use any psychotropic drugs or undergo ECT during the course of the trial.
Outcomes HDRS
Adverse events
Time needed to respond to treatment
Response (≥50% reduction in the HDRS score
Remission (HDRS score ≤7)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed by the permuted randomization block method using a computerized random number generator by an independent party (allocation ratio 1:1, blocks of four)"
Allocation concealment (selection bias) Low risk Quote: "Allocation concealment was performed using sequentially numbered, sealed, opaque, and stapled envelopes. An aluminum foil inside the envelope rendered the content of envelope impermeable to intense light. Riluzole and placebo tablets were identical in their size, shape, color, texture and odor. The patients, the nurses, the physician who referred the patient, the investigator, and the raters were all blinded to treatment allocation"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "The patients and the raters guessed wrongly about the allocated treatment in more than 50% of allocations"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The patients and the raters guessed wrongly about the allocated treatment in more than 50% of allocations"
Incomplete outcome data (attrition bias)
All outcomes Low risk Flow diagram of patients in the study and reasons for trial discontinuation included in figure 1 (page 27).
Selective reporting (reporting bias) Low risk Trial registration available online (IRCT201307181556N54), all outcomes reported as planned.
Other bias Low risk None identified