Strik 2000.
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 54 Length of follow‐up: No follow‐up Analysis: Intention‐to‐treat for primary outcomes (9 withdrawn in control, 5 withdrawn in treatment group), per‐protocol for cardiologic safety variables |
|
| Participants | Location: Netherlands Number of study centres and setting: Patients from 2 hospitals CAD criteria: Myocardial Infarction (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 U/liter); 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 Hamilton Rating Scale for Depression (HAM‐D) score of >17 were included Other entry criteria: 18 to 75 years Exclusion criteria: Any concurrent psychosocial or therapeutic intervention, psychotic symptomatology, a second psychiatric diagnosis, history of mania, current pregnancy or lactation, life‐threatening noncardiac physical illness, concurrent use of psychotropic drugs, hypersensitivity to fluoxetine, liver or severe kidney dysfunction, right ventricular filling pressure >30 mm Hg 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 |
|
| 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 |
|
| Outcomes | Review outcomes: Depression remission defined as a HAM‐D end‐point score of < 7, death, rehospitalization due to cardiac events Other outcomes: SCL‐90 Hostility Scale score, concurrent use of medications, cognitive performance, non‐cardiac life‐threatening disease, blood pressure, electrocardiographic variables (heart rate, PR interval, QRS interval, QT interval), echocardiographic variables (LVEF, ATVI, E/A ratio) |
|
| 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 (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind" (p. 785) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: 14 patients meeting inclusion criteria were not included, 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 | High risk | Comment: Conflicting interests: Funded by Eli Lilly |