CREATE 2007.
| Methods | RCT design: 2 x 2 factorial trial Total N randomised: 284 Length of follow‐up: No follow‐up Analysis: Intention‐to‐treat (ITT) with last‐observation‐carried‐forward applied for missing data |
|
| Participants | Location: Canada Number of study centres and setting: 9 hospitals with patients being referred from physicians, responded to media advertisements or targeted posters CAD diagnosis: Evidence of CAD based on hospital chart evidence of a previous hospitalization for acute myocardial infarction, or coronary angiographic evidence of 50% or more blockage in at least one major coronary artery, or previous revascularization; patients were not randomised less than 1 week following discharge Depression diagnosis: Current major depressive episode based on the Structured Clinical Interview for Depression (SCID) with at least 4 weeks' duration; baseline score of >19 on the Hamilton Depression Rating Scale (HAM‐D) Other entry criteria: Adult patients (18 years or older), stable CAD according to physician's clinical judgement Exclusion criteria: Coronary bypass surgery planned during the next 4 months, Canadian Cardiovascular Society Angina Class (CCS) = 4, bipolar disorder, major depression with psychotic features, or evidence of substance abuse or dependency during the previous 12 months, serious suicide risk based on clinical judgement, use of antidepressants, lithium, or anticonvulsants for mood disorder, currently undergoing any form of psychotherapy, absence of response to a previous adequate trial of citalopram or IPT, two previous unsuccessful trials of treatment for depression for the index episode, lifetime history of early termination (<8 weeks) of citalopram because of adverse events or side effects, lifetime history of early termination (<8 weeks) of two other SSRI antidepressants because of adverse events or side effects, significant cognitive problems, depression due to a general medical condition based on clinical judgement, participation in other trials, inability to speak English or French, unable or willing to comply with the study regimen Treatment 1 N: 142 (31.0% female, mean age: 59.0 (SD: 9.81)) Treatment 2 N: 142 (23.2% female, mean age: 57.9 (SD: 9.15)) Control 1 N: 142 (18.3 % female, mean age: 57.3 (SD: 8.35)) Control 2 N: 142 (26.1% female, mean age: 58.4 (SD: 9.16)) Comparability of groups: Significantly more women in IPT compared to CM |
|
| Interventions | Treatment 1: Interpersonal Psychotherapy (IPT) + CM provided weekly by certified therapists following published treatment guidelines dealing with common problems in CAD patients, including interpersonal conflicts, life transitions, grief, loss, and social isolation Treatment 2: Citalopram + CM (20‐mg/d to 40 mg/d, tablets) Control 1: Clinical management (CM) with 20‐ to 25‐minute visits including information about depression and medication use, reassurance, and encouragement of adherence to medication and the study protocol, review of side effects and progress Control 2: Placebo administration matched to citalopram condition Duration of treatment: 12 weeks |
|
| Outcomes | Outcomes: HAM‐D score, depression remission (HAM‐D <= 8), Beck Depression Inventory II (BDI‐II), cardiac events Other outcomes: Interpersonal Relationships Inventory (IPRI), Functional Performance Inventory (FPI), ECG, blood pressure |
|
| Funding | Canadian Institute of Health Research; Fondation du Centre Hospitalier de l'Université de Montréal; Fondation de l'Institut de Cardiologie de Montréal; Citalopram and matching placebo donated by Lundbeck Canada Inc. | |
| Notes | Factorial design allowed for two randomised comparisons of main effects: 1) IPT vs. CM, 2) Citalopram vs. Placebo | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Computer generated block randomisation |
| Allocation concealment (selection bias) | Low risk | Quote: "Concealed in sequentially numbered, site‐specific, sealed opaque envelopes stored at the coordinating center until randomization." (p. 369) |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: Pharmacological intervention arm: Therapists, patients, site psychiatrists, telephone raters for primary outcome, and other personnel blinded to assignment regarding Citalopram treatment Comment: Psychological intervention arm: Telephone rater for primary outcome assessment blinded to patients' allocation to IPT vs. CM |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Intention‐to‐treat (ITT) analysis with last‐observation‐carried‐forward |
| Selective reporting (reporting bias) | Low risk | Comment: Primary and secondary outcomes reported in accordance with the study protocol (ISRCTN15858091) |
| Other bias | High risk | Comment: Conflicting interests: Citalopram and matching placebo donated by Lundbeck Canada Inc. |