Characteristics of Randomized Controlled Trials of Depression Treatment.

*The International Committee of Medical Journal Editors (ICMJE) clinical trial registration policy requires prospective registration (i.e., prior to patient enrollment) of trials that began on or after July 1, 2005, and also requires registration of trials that were ongoing as of July 1, 2005 (i.e., registration after the beginning of patient enrollment).
†Factorial design with patients randomized to citalopram or placebo and IPT or CM.
‡Of the 2,481 randomized patients in the ENRICHD trial who met eligibility criteria for MDD, minor depression, or dysthymia and/or low social support [31], data are reported only for the subset of 955 randomized patients diagnosed with MDD at trial entry. Original data for the ENRICHD trial were obtained from the National Heart Lung and Blood Institute.
§Maximum duration of the CBT intervention was 6 months. Group therapy could extend 12 additional weeks and adjunctive sertraline treatment for up to 12 months.
∥The Honig, 2007 [32] study was an RCT nested within the MIND-IT study [33].
¶Outcome at 8 weeks were reviewed instead of 24-week results because 8 weeks open treatment with citalopram was offered in the case of refusal or insufficient treatment response [33].
#Author-industry financial ties were not reported. The authors of the MIND-IT trial [33], of which the Honig, 2007 study [32] was a nested RCT, declared no conflicts of interest. However, of the 12 authors of the Honig, 2007 study [32] only 9 were authors of the published MIND-IT report [33].
**Long-term cardiovascular outcomes from Glassman AH, Bigger JT,Jr, Gaffney M. Psychiatric characteristics associated with long-term mortality among 361 patients having an acute coronary syndrome and major depression: Seven-year follow-up of SADHART participants. Arch Gen Psychiatry. 2009 Sep;66:1022–9. ACS = acute coronary syndrome; AMI = acute myocardial infarction; CBT = cognitive behavior therapy; CHD = coronary heart disease; CM = clinical management; CREATE = Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy trial; ENRICHD = Enhancing Recovery in Coronary Heart Disease Patients; HF = heart failure; IPT = interpersonal therapy; MIND-IT = Myocardial Infarction and Depression-Intervention trial; NA = not applicable; NR = not reported; SADHART = Sertraline Antidepressant Heart Attack Randomized trial; SADHART-CHF = Sertraline Against Depression and Heart Disease in Chronic Heart Failure; Tx = treatment; UC = usual care.