Abbasi 2015.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 58 Length of follow‐up: no follow‐up Analysis: per‐protocol (6 dropouts in the simvastatin group, 6 dropouts in the atorvastatin group) |
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| Participants | Location: Iran Number of study centres and setting: patients who had undergone CABG from Psychiatric Clinic of Tehran Heart Center CAD criteria: history of post‐CABG in the last 6 months Depression criteria: patients who met the DSM IV‐TR criteria for diagnosis of MDD, confined to patients with mild‐to‐moderate depression and a HAM‐D score of ≤ 19 Other entry criteria: patients aged 18 to 50 years Exclusion criteria: participants with any diagnosis other than MDD on the DSM‐IV‐TR axis I or II, on any psychotropic medications or presence of any psychotic features, receiving any antidepressant medication in the last month, receiving electroconvulsive therapy during the last 2 months, serum low‐density lipoprotein level of < 80, history of hypothyroidism, hepatic diseases, alcohol or substance (with exception of nicotine) dependence, receiving any statins or any other lipid‐lowering agent during the last 2 months, hypersensitivity to statins, presence of any serious medical condition or neurological problem, high levels of liver aminotransferases, pregnancy and lactations, behavioural intervention therapy Treatment N: 23 (30.4% female, mean age: 56.87 (SD: 6.90)) Control N: 23 (34.8% female, mean age: 57.70 (SD: 7.26)) Comparability of groups: no significant baseline differences |
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| Interventions | Treatment: 1 tablet of simvastatin once daily (20 mg tablets) Control: 1 tablet of atorvastatin once daily (20 mg tablets) Duration of treatment: 6 weeks |
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| Outcomes | Review outcomes: depression symptoms (HAM‐D), depression response (50% reduction on HAM‐D), cardiac events, pharmacological side effects (checklist) | |
| Funding | Tehran University of Medical Sciences | |
| Notes | The title says "...placebo‐controlled, randomized trial...", but both groups received a drug treatment. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Computer generated block randomisation carried out by an independent party |
| Allocation concealment (selection bias) | Low risk | Comment: Opaque, sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: Participants, research investigators, rater and statistician blinded to treatment allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: primary outcome (HAMD) rater blinded to treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: per‐protocol analysis and authors reported reasons for early drop‐out per group |
| Selective reporting (reporting bias) | Unclear risk | Comment: trial registry measurement points (week 2, 4, 6) differ from reported measurement points (week 3, 6) |
| Other bias | Low risk | Comment: no indication of other bias |