MIND‐IT 2007.
| Study characteristics | ||
| Methods | RCT design: nested, 3‐arm parallel‐group trial Total N randomised: 91 Length of follow‐up: no follow‐up Analysis: ITT (10 dropouts in the intervention group, 3 dropouts in the placebo group during the first 8‐week acute treatment phase; 23 dropouts in the intervention group, 15 dropouts in the placebo group during the entire treatment (24 weeks)) |
|
| Participants | Location: Netherlands Number of study centres and setting: patients with a MI from 8 hospitals CAD criteria: MI with typical clinical picture, increase of cardiac enzymes, 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 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: occurrence of MI whilst hospitalised 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 |
|
| Interventions | Treatment: mirtazapine (30 to 45 mg/d); participants who did not respond and those with relapse were offered open treatment with citalopram Control 1: placebo Control 2: care as usual, pharmacological treatment, non‐pharmacological treatment, or no treatment (not eligible for this review) Duration of treatment: 24 weeks (8 weeks acute plus 16 weeks continuation treatment) |
|
| Outcomes | Review outcomes: depression symptoms (HAM‐D, also BDI, depression scale of the SCL 90), depression remission (HAM‐D ≤ 7), all‐cause mortality, cardiac events, hospitalisations, cardiovascular vital signs (BP, HR), platelet biomarkers, ECG waves, pharmacological side effects Other outcomes: clinical global impression, concurrent medication, weight |
|
| Funding | Netherlands Heart Foundation; Organon (Netherlands); Lundbeck (Denmark) | |
| Notes | MIND‐IT trial investigated antidepressant treatment in general versus usual care in patients following MI (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. We used data for the nested trial investigating mirtazapine versus placebo (n = 91) in this review consistent with the predefined 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: Insufficient information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Insufficient information provided Quote: "double‐blind" (Honig 2007, pg. 607) |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Insufficient information provided in primary nested‐trial paper (Honig 2007). Quote: From protocol " A blinded end point committee will judge all possible primary end points" (van den Beek 2002, pg. 223) |
| 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 in Honig (2007) Comment: Analysis of nested‐study trial data not stated in protocol paper (van den Brink, 2002) |
| Other bias | Unclear risk | Comment: in the paper by Honig patients randomised to mirtazapine had higher baseline scores on depression (HAM‐D, p = 0.05) which suggests possible baseline imbalance |