Strik 2000.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 54 Length of follow‐up: no follow‐up Analysis: ITT for primary outcomes (9 withdrawn from control group, 5 withdrawn from treatment group), per‐protocol for cardiologic safety variables |
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| Participants | Location: Netherlands Number of study centres and setting: patients from 2 hospitals CAD criteria: MI diagnosed by a cardiologist with a clinical picture typical of MI, electrocardiographic changes specific for MI, and a maximum plasma concentration of aspartate aminotransferase (ASAT) of twice the upper normal range (80 units/litre); enrolment 3 to 12 months after MI Depression criteria: patients with a score above the cut‐off on the SCL‐90 Depression Scale (> 22 for men and > 28 for women) were interviewed with the Schedules for Clinical Assessment in Neuropsychiatry; patients meeting DSM‐III‐R criteria for major depressive episode and having a HAM‐D score of > 17 were included Other entry criteria: 18 to 75 years of age Exclusion criteria: any concurrent psychosocial or therapeutic intervention, psychotic symptomatology, a second psychiatric diagnosis, history of mania, current pregnancy or lactation, life‐threatening non‐cardiac physical illness, concurrent use of psychotropic drugs, hypersensitivity to fluoxetine, liver or severe kidney dysfunction, right ventricular filling pressure > 30 mmHg and a low systolic volume or an ATVI < 10 cm Treatment N: 27 (22% female, mean age: 54.1 (SD: 11.3)) Control N: 27 (37% female, mean age: 58.7 (SD: 10.1)) Comparability of groups: no significant baseline differences |
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| Interventions | Treatment: fluoxetine (acute treatment period of 9 weeks and continuation period of 16 weeks; 20 to 60 mg/d) Control: placebo Duration of treatment: maximum of 25 weeks |
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| Outcomes | Review outcomes: depression symptoms (HAM‐D), depression remission (HAM‐D < 7), cardiac events, resource utilisation (hospitalisation), cardiovascular vital signs (BP, HR), ECG waves, pharmacological side effects Other outcomes: SCL‐90 Hostility Scale score, concurrent use of medications, cognitive performance, echocardiography (LVEF, ATVI, E/A ratio) |
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| Funding | Eli Lilly, Dutch Prevention Fund, Maastricht University Hospital Research Fund | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No details reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: No details reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐blind" (pg. 785) |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blind" (pg. 785) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 14 patients meeting inclusion criteria did not complete the trial, but did not differ from participants in age, gender, or maximum ASAT Comment: Intention‐to‐treat for primary outcomes |
| Selective reporting (reporting bias) | High risk | Comment: Many outcomes not or only partially reported Comment: No protocol or design paper available |
| Other bias | Low risk | Comment: No indication of other bias |