Roose 1998.
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 81 Length of follow‐up: No follow‐up Analysis: Intention‐to‐treat (4 Paroxetine patients discontinued, 10 Nortriptyline patients discontinued) |
|
| Participants | Location: USA Number of study centres and setting: Outpatients from 4 hospitals CAD criteria: Myocardial infarction (MI), coronary artery bypass grafting, coronary angioplasty, positive stress test, or angiographic evidence of a 75% or greater luminal narrowing of a major coronary artery; time to randomisation unclear Depression criteria: Meeting DSM‐IV criteria for major depressive disorder, unipolar subtype, with a score of 16 or greater on the 17‐item Hamilton Rating Scale for Depression (HAM‐D) Other entry criteria: Age >= 18 Exclusion criteria: MI within the past 3 months, a baseline QTc interval of 460 milliseconds or greater, unstable or crescendo angina, receiving drugs with class 1 antiarrhythmic activity or warfarin Treatment 1 N: 41 (12% female, mean age: 57.8 (SD: 11.0)) Treatment 2 N: 40 (22% female, mean age: 57.9 (SD: 12.7)) Comparability of groups: No significant baseline differences |
|
| Interventions | Treatment 1: Paroxetine (+ dummy placebo at night) (age < 65: 20 mg/d for the first 3 weeks; age > 65: 10 mg/d for the first week, 20 mg/d for week 2 and 3; if no response (HAM‐D reduction 50% or HAM‐D <= 8) 30 mg/d at week 4 and 40 mg/d at end of week 5) Treatment 2: Nortriptyline (+ dummy placebo in the morning) (25 mg for the first 2 days; 50 mg on day 3; on day 7 plasma level measurement and adjustment of the dose to achieve a nortriptyline plasma level between 203 and 456 nmol/L (80‐120 ng/mL)) Duration of treatment: 6 weeks |
|
| Outcomes | Review outcomes: HAM‐D depression score, depression remission rate (HAM‐D score of 8 or less) Other outcomes: Heart rate, blood pressure, PR interval, QRS interval, QT interval, heart rate variability (SDNN, pNN50), adverse events |
|
| Funding | Smith‐Kline Beecham Pharmaceuticals (GlaxoSmithKline) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomized by permuted blocks of 10" (p. 288) |
| Allocation concealment (selection bias) | Unclear risk | Comment: No details reported |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Double dummy technique" (p. 288) |
| 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 Smith‐Kline Beecham Pharmaceuticals |