MIND‐IT 2007.
| Methods | RCT design: Nested, 2‐arm parallel‐group trial Total N randomised: 91 Length of follow‐up: No follow‐up Analysis: Intention‐to‐treat (10 drop‐outs in the intervention group compared to 3 in the placebo group during the first 8‐week acute treatment phase, 23 drop‐outs in the intervention group compared to 15 in the placebo group during the entire treatment (24 weeks)) |
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| Participants | Location: Netherlands Number of study centres and setting: Patients with a Myocardial Infarction (MI) from 8 hospitals CAD criteria: MI with typical clinical picture, increase of cardiac enzymes, electrocardiographic (ECG) changes and chest pain for > 20 minutes; time to randomisation 3 to 12 months (to exclude adjustment disorders) Depression criteria: 2‐stage procedure, in which those with 1) score of 10 or more on the Beck Depression Inventory (BDI) were 2) interviewed with the Composite International Diagnostic Interview (CIDI) for major or minor depression diagnosis (psychiatrist confirmed CIDI diagnosis) Other entry criteria: age >= 18 years Exclusion criteria: Occurence of MI while hospitalized for another reason, except for unstable angina pectoris, lacking capability to participate in study procedures, any disease likely to influence short‐term survival, already receiving psychiatric treatment for depressive disorder, participation in any clinical trial that might intervene with the study, hyperthyroidism, suicidality Treatment N: 47 (12.8% female, mean age: 56.6 (SD: 11.1)) Control N: 44 (18.2% female, mean age: 57.9 (SD: 9.7)) Comparability of groups: No significant baseline differences |
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| Interventions | Treatment: Mirtazapine (30 to 45 mg/d); patients who did not respond and patients with relapse were offered open treatment with citalopram Control: Placebo Duration of treatment: 24 weeks (8 weeks acute plus 16 weeks continuation treatment) |
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| Outcomes | Review outcomes: Hamilton Depression Rating Scale (HAM‐D) score, depression remission (HAM‐D <= 7), BDI score, depression scale of the Symptom Checklist 90 item (dSCL‐90), cardiac events Other outcomes: Clinical Global Impression (CGi), side effects, concurrent medication, weight, heart rate, blood pressure, PR interval, QRS interval, QT interval |
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| Funding | Netherlands Heart Foundation; Organon (Netherlands); Lundbeck (Denmark) | |
| Notes | MIND‐IT trial investigated antidepressant treatment in general versus usual care in patients following myocardial infarction (N = 331). The intervention arm consisted of double‐blind Mirtazapine, open pharmacological treatment, non‐pharmacological treatment or no treatment. The care as usual arm comprised pharmacological treatment, non‐pharmacological treatment or no treatment. Data of the nested trial investigating mirtazapine versus placebo (n = 91) was used in this review due to the pre‐defined comparisons (i.e. pharmacological intervention vs. placebo). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Central randomization service (computer‐generated blocks of four) |
| Allocation concealment (selection bias) | Unclear risk | Comment: No details reported |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind" (p. 607) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: ITT with last observation carried forward |
| Selective reporting (reporting bias) | Unclear risk | Comment: Results and methods section consistent Comment: No protocol or design paper available |
| Other bias | High risk | Comment: Conflicting interests: Funded by Organon (Netherlands) and Lundbeck (Denmark) |