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) |
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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) |
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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 |