Divsalar 2018.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel trial Total N randomised: 101 Length of follow‐up: no follow‐up Analysis: ITT with last‐observation‐carried‐forward (3 dropouts from sertraline/red yeast arm, 3 dropouts from sertraline/placebo arm) |
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| Participants | Location: Iran Number of study centres and settings: Imam Hospital and Tehran Heart Center CAD criteria: history of coronary angioplasty Depression criteria: diagnosis of major depressive disorder (MDD) based on DSM‐V and HAM‐D score of ≥ 20 Other entry criteria: aged 18 to 60 years old Exclusion criteria: other DSM‐V disorders other than MDD; presence of psychotic features or suicidal ideation; inability to communicate; consumption of psychotropic or antidepressant medications in the last month prior to the study; electroconvulsive therapy in the last 2 months prior to study; lipid‐lowering agents (e.g. statins) in the last 2 weeks prior to the study; hypersensitivity to statins; presence of neurological diseases or serious medical condition or history of hepatic disease or hypothyroidism; elevated serum aminotransferases to serum LDL (80 mg/dL); pregnancy or lactation Treatment: 25 (28% women, mean age: 43.52 (SD: 6.36)) Control: 25 (40% women, mean age: 44.32 (SD: 5.47)) Comparability of groups: no significant baseline differences |
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| Interventions | Intervention 1: sertraline (200 mg/day) and red yeast rice (2500 mg/day) Intervention 2: sertraline (200 mg/day) and placebo Duration of treatment: 6 weeks |
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| Outcomes | Review outcomes: depression symptoms (HAM‐D), pharmacological side effects (25‐item checklist) | |
| Funding | Tehran University of Medical Sciences (TUMS) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Computerized random number generation was used |
| Allocation concealment (selection bias) | Low risk | Quote pg. 71 "Computerized random number generation was used by one of the personnel different from raters" Comment: Allocation was achieved using sealed opaque envelopes with sequential numbers |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: All healthcare providers, participants, and caregivers were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote pg. 71 "An independent rater was responsible for administration of the HDRS at weeks 0, 3, and 6." Comment: unclear blinding for other outcomes including biomarkers |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: The reasons for patients who did not complete the intervention were reported |
| Selective reporting (reporting bias) | Unclear risk | Comment: No protocol or design paper available |
| Other bias | High risk | Comment: selection bias evident with 14.9% of participants who were eligible for the study but were excluded prior to randomisation |